365 Medicated Lip Balm
365 Medicated Lip Balm is an FDA drug label for the active ingredient MEDICATED LIP BALM manufactured by Whole Foods Market, Inc. 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 20231103.
- Generic name
- MEDICATED LIP BALM
- Manufacturer
- Whole Foods Market, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 42681-0001
- Application
- M017
- Label effective
- 20231103
About this product
365 Medicated Lip Balm is an FDA-registered drug product whose active ingredient is MEDICATED LIP BALM. It is labelled by Whole Foods Market, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 42681-0001, application M017, label effective 20231103. 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.
Active ingredients
Dosage & Administration
Directions ■ Adults and children 2 years of age and older: Apply to lips not more than 3 to 4 times daily ■ Children under 2 years of age: consult a doctor.
Warnings
Warnings For external use only. When using this product avoid contact with eyes. Stop use and ask a doctor if ■ Condition worsens ■ Symptoms last more than 7 days or clear up and occur again within a few days. Keep out of the reach of children. Do not use on: deep puncture wounds, serious burns, animal bites. If swallowed, get medical help or contact a Poison Control Center immediately.
Frequently asked questions
What is 365 Medicated Lip Balm used for?
No indications section is present in the FDA label on file for this product. Consult the prescribing information supplied with the medicine or ask a pharmacist.
Who makes 365 Medicated Lip Balm?
Whole Foods Market, Inc. is the labeler of record for 365 Medicated Lip Balm.
What form does 365 Medicated Lip Balm 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 365 Medicated Lip Balm 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.
Has 365 Medicated Lip Balm 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.