Sponge with 4% w/w chlorhexidine gluconate (CHG)
Sponge with 4% w/w chlorhexidine gluconate (CHG) is an FDA drug label for the active ingredient CHLORHEXIDINE GLUCONATE manufactured by Xinxiang Xinda Technology Co.,Ltd 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 20260611.
- Generic name
- CHLORHEXIDINE GLUCONATE
- Manufacturer
- Xinxiang Xinda Technology Co.,Ltd
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 84128-013
- Application
- 505G(a)(3)
- Label effective
- 20260611
About this product
Sponge with 4% w/w chlorhexidine gluconate (CHG) is an FDA-registered drug product whose active ingredient is CHLORHEXIDINE GLUCONATE. It is labelled by Xinxiang Xinda Technology Co.,Ltd taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 84128-013, application 505G(a)(3), label effective 20260611. It is one of 38 FDA drug label records sharing the active ingredient CHLORHEXIDINE GLUCONATE. 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 CHLORHEXIDINE GLUCONATE are most often described in connection with: preoperative cleaning, healthy skin, human hygiene, significantly reduces, number micro-organisms, prior surgery. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use Preoperative cleaning of healthy skin,disinfectant for human hygiene.Significantly reduces the number of micro-organisms and clean on the health skin prior to surgery.
Dosage & Administration
Directions • Wet the health skin with water. Rinse for 2 to 3 minutes and rub skin to produce foam. • Clarify with water and dry with a sterile towel.
Warnings
Warnings For external use only. Do not use it for a long time . if redness or irritation occurs. When using this product avoid contact with eyes. Stop use and ask a doctor if severe adverse reactions occur. Keep out of reach of children. If swallowed or gets in eyes,get medical help or contact a Poison Control Center immediately.
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View labelHow products containing CHLORHEXIDINE GLUCONATE compare
FDA lists 38 drug label records with CHLORHEXIDINE GLUCONATE 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 |
|---|---|---|---|
| — | — | Xttrium Laboratories, Inc. | 11 |
| — | — | AVA, Inc. | 9 |
| — | — | Colgate Oral Pharmaceuticals, Inc. | 2 |
| — | — | SC Johnson Professional USA, Inc. | 2 |
| — | — | XINXIANG XINDA TECHNOLOGY CO.,LTD | 2 |
Frequently asked questions
What is Sponge with 4% w/w chlorhexidine gluconate (CHG) used for?
Use Preoperative cleaning of healthy skin,disinfectant for human hygiene.Significantly reduces the number of micro-organisms and clean on the health skin prior to surgery.
Who makes Sponge with 4% w/w chlorhexidine gluconate (CHG)?
Xinxiang Xinda Technology Co.,Ltd is the labeler of record for Sponge with 4% w/w chlorhexidine gluconate (CHG). 38 FDA label records share the active ingredient CHLORHEXIDINE GLUCONATE, 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 Sponge with 4% w/w chlorhexidine gluconate (CHG) 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 Sponge with 4% w/w chlorhexidine gluconate (CHG) 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 CHLORHEXIDINE GLUCONATE?
Yes. 38 FDA drug label records list CHLORHEXIDINE GLUCONATE 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 Sponge with 4% w/w chlorhexidine gluconate (CHG) been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
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.