Blistex Maximum Hydration Lip

CAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOL TOPICAL HUMAN OTC DRUG

Blistex Maximum Hydration Lip is an FDA drug label for the active ingredient CAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOL manufactured by Blistex 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 20260518.

Generic name
CAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOL
Manufacturer
Blistex Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
10157-9913
Application
M017
Label effective
20260518

About this product

Blistex Maximum Hydration Lip is an FDA-registered drug product whose active ingredient is CAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOL. It is labelled by Blistex Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 10157-9913, application M017, label effective 20260518. 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 CAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOL are most often described in connection with: temporary relief, itching associated, minor lip, irritation cold, sores temporarily, helps relieve, chapped cracked. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients Purpose Camphor 0.5% (w/w) External analgesic Dimethicone 1.1% (w/w) Lip protectant Menthol 0.625% (w/w) External analgesic Phenol 0.5% (w/w) External analgesic

Indications & Usage

Uses for the temporary relief of pain and itching associated with minor lip irritation or cold sores temporarily protects and helps relieve chapped or cracked lips

Dosage & Administration

Directions adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily children under 2 years of age: Consult a doctor

Warnings

Warnings For external use only Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes do not apply over large areas of the body or bandage 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently asked questions

What is Blistex Maximum Hydration Lip used for?
Uses for the temporary relief of pain and itching associated with minor lip irritation or cold sores temporarily protects and helps relieve chapped or cracked lips

Who makes Blistex Maximum Hydration Lip?
Blistex Inc. is the labeler of record for Blistex Maximum Hydration Lip.

What form does Blistex Maximum Hydration Lip 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 Blistex Maximum Hydration Lip 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 Blistex Maximum Hydration Lip 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.