ACOLYE Lidocaine Cream Topical Analgesia Cream

ACOLYE Lidocaine Cream Topical Analgesia Cream is an FDA-registered drug product whose active ingredient is LIDOCAINE,MENTHOL. It is labelled by Guangdong Aimu Biological Technology Co., Ltd taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 83566-617, application M017, label effective 20260730. 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.

Across FDA labelling, products containing LIDOCAINE,MENTHOL are most often described in connection with: temporary relief, itching associated, minor burns, cuts scrapes, insect bites, skin irritations, fever blisters, cold sores. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. For the temporary relief of itching associated with fever blisters and cold sores.

Directions Adults and children 12 years of age and older: - Clean affected area with mild soap and warm water, if needed. - Apply a thin layer to the affected area not more than 3 to 4 times daily. - Gently massage until absorbed. If pregnant or breast-feeding, ask a health professional before use. Children under 12 years of age: Do not use. Ask a doctor.

Warnings For external use only.

What is ACOLYE Lidocaine Cream Topical Analgesia Cream used for?
Uses For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. For the temporary relief of itching associated with fever blisters and cold sores.

Who makes ACOLYE Lidocaine Cream Topical Analgesia Cream?
Guangdong Aimu Biological Technology Co., Ltd is the labeler of record for ACOLYE Lidocaine Cream Topical Analgesia Cream.

What form does ACOLYE Lidocaine Cream Topical Analgesia Cream 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 ACOLYE Lidocaine Cream Topical Analgesia Cream 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 ACOLYE Lidocaine Cream Topical Analgesia Cream 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.