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.
Other
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(S)
Camphor 10%. Purpose: Topical Analgesic
Purpose
Topical Analgesic
Use
For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Warnings
For external use only. Flammable. Avoid contact with the eyes. Do not bandage tightly or apply to wounds or damaged skin.
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 symtpoms persist for more than 7 days or clear up and occur again within a few days.
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 thorougly. Apply to affected area not more than 3 to 4 times a day.
Other Information
- Store between 15-30C (59-86F)
- Do not expose to excessive heat
Inactive Ingredients
cyclomethicone, white petrolatum
Package Label - Principal Display Panel
70g NDC: 82165-103-02
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