White Tea
White Tea is an FDA drug label for the active ingredient BENZALKONIUM CHLORIDE manufactured by Apollo Health and Beauty Care administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260508.
- Generic name
- BENZALKONIUM CHLORIDE
- Manufacturer
- Apollo Health and Beauty Care
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 63148-325
- Application
- 505G(a)(3)
- Label effective
- 20260508
About this product
White Tea is an FDA-registered drug product whose active ingredient is BENZALKONIUM CHLORIDE. It is labelled by Apollo Health and Beauty Care taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 63148-325, application 505G(a)(3), label effective 20260508. It is one of 231 FDA drug label records sharing the active ingredient BENZALKONIUM CHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing BENZALKONIUM CHLORIDE are most often described in connection with: handwashing decrease. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses for handwashing to decrease bacteria on the skin.
Dosage & Administration
Directions Wet hands. Apply palmful to hands. Lather vigorously. Rinse and dry thoroughly.
Warnings
Warnings For external use only. Hands only. When using this product avoid contact with eyes. If this occurs, rinse eyes with water. Stop use and ask a doctor if irritation or redness develops and lasts. Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center immediately.
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View labelHow products containing BENZALKONIUM CHLORIDE compare
FDA lists 231 drug label records with BENZALKONIUM CHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | USA Broom LLC | 28 |
| — | — | Apollo Health and Beauty Care | 11 |
| — | — | Enviro Specialty Chemicals Inc | 11 |
| — | — | H E B | 10 |
| — | — | Jianerkang Medical Co., Ltd | 7 |
Recall and safety notices
3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-1371-2022 | SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E 7.5FLOZ SKU 2007700 SOFTSOAP LHS CC ANTIBAC ORANGE 50 FL OZ SKU 2007708 SPA SOAP ANTIBAC GLD LHS PUMP 20.2 FL OZ SKU 2097440 DIAL FOAMING LHS POWER BERRIES 7.5 FL OZ SKU 2044098 SOFTSOAP LIQUID HAND SOAP FERSH CITRUS AB 11.25 FL OZ SKU 2005088 SPA SOAP HNDSP ANTBCTRL ULTR2X GLD 64 FL OZ SKU 2008290 DIAL FOAMING LHS SPRING WATER 7.5 FL OZ SKU 2044177 DAWN ULTRA ANTIBAC APL BLOSSOM 21.6 FLOZ SKU 1498425 DAWN ULTRA APPLE 15.5 FL OZ SKU 1414227 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | Family Dollar Stores, Llc. | Class II | Ongoing | 20220831 |
| D-750-2014 | Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UPC 3 0043-6403-24 7); b) 12-count packets per carton containing 6-count Daytime and 6-count Nighttime packets (UPC 3 0043-6403-12 4); Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. | Novartis Consumer Health | Class II | Terminated | 20140129 |
| D-756-2014 | Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06. Also packaged under foreign label: NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9. | Novartis Consumer Health | Class II | Terminated | 20140129 |
Frequently asked questions
What is White Tea used for?
Uses for handwashing to decrease bacteria on the skin.
Who makes White Tea?
Apollo Health and Beauty Care is the labeler of record for White Tea. 231 FDA label records share the active ingredient BENZALKONIUM CHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does White Tea come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is White Tea prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing BENZALKONIUM CHLORIDE?
Yes. 231 FDA drug label records list BENZALKONIUM CHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has White Tea been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.