FDA Label for Hand Sanitizer
View Indications, Usage & Precautions
Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Rebel Rebel Personal Care 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)
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
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 irritation or rash occurs. These may be signs of a serious condition.
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
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.
Recent Major Changes
Changes to:
- Recommended Use: Antiseptic (skin) cleanser to help reduce bacteria on skin.
- Direction: 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).
- 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.
Package Label - Principal Display Panel
60 mL NDC: 82092-001-01
60 mL NDC: 82092-002-01
60 mL NDC: 82092-003-01
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