HAND SANITIZER- alcohol liquid
Rebel Rebel Personal Care Corp.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
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)
Ethyl Alcohol 65%. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Antiseptic (skin) cleanser to help reduce bacteria on skin.
Warnings
Keep out of reach of children. For external use only. Flammable. Keep away from flame and heat. When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water. If swallowed get medical help or contact poison control centre right away.
Do not use
- in children less than 2 months of age
- on open skin wounds
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.
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.
Directions
Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children to avoid swallowing. Store between 15-30°C (59-86°F).
Other information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients
Non Active Ingredients: Purified Water, Aloe Barbadensis Extract, Glycerin, Polysorbate 20, Denatonium Benzoate, Fragrance.
Package Label - Principal Display Panel
60 mL NDC: 82092-001-01
60 mL NDC: 82092-002-01
60 mL NDC: 82092-003-01
Rebel Rebel Personal Care Corp.