FDA Label for Topical Analgesic
View Indications, Usage & Precautions
Topical Analgesic Product Label
The following document was submitted to the FDA by the labeler of this product Dermaline Usa Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Menthol 1%. Purpose: Topical Analgesic
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
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