Active Ingredient(S)
Menthol 1%. Purpose: Topical Analgesic
Topical Analgesic
FDA Label NDC 82165-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dermaline Usa Corp for the product Topical Analgesic (NDC 82165-104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic, Gel
Use
For temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritation.
Warnings
For external use only. Flammable. Keep away from fire or flames.
Avoid Contact with eyes. Do not bandage tightly.
Do not apply over large areas of the body.
Do Not Use
- on children under 16 years of age except on the advice of a physician.
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Incase accidental ingestion, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 16 years of age and older: Wash the affected area with mild soap and warm
water and rinse thoroughly. Apply to affected area not more than 3 to 4 times daily.
Do not bandage tightly or apply to wounds or damaged skin.
Children under 16 yeats of age: consult a doctor.
Other Information
- Store between 15-30C (59-86F)
- Do not expose to excessive heat.
Inactive Ingredients
Arnica Extract, Camphor, Carbomer, Deionized Water, DMDM Hydatoin, Ethyl Alcohol, Eucalyptus Oil, Isopropyl Alcohol, Nonoxynol-9, polysorbate 20, propyleneglycol, Tea Tree Oil, Trirthanolamine.
Package Label - Principal Display Panel
141 g
* Please review the disclaimer below.
