Dermaline Camphor Ointment

SPL UNCLASSIFIED SECTION

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:

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

• 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.

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 SECTION

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 SECTION

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 SECTION

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