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 Samara Cosmetics S.a.s.. 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)
Alcohol 68% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
* Helps eliminate bacteria on the hand and parts of the body that needs to be cleaned. This product is not a substitute of soap hand washing. Avoid contact with broken or damaged skin
Warnings
- For external use only-
- When using this product keep out o f eyes. In case of contact, flush with water several minutes.
- Keep out of reach of children except under adult supervision
- If swalow get medical help or contact a Poison Control Center right away.
- Flammable: Keep away from heat and flame.
- Stop use and ask Doctor: if skin irritation develops.
- Do not swalow
- Children under 6 years old should be supervised when using this product
Do Not Use
Stop use and ask a doctor if
* Irritation develops
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
- Place enough product in your palm to throughly cover your hands.
- Rub hands together briskly until dry
- Apply it on the parts of the body that needs to be cleaned and rub it briskly until dry
Other Information
QUESTIONS OR COMMENTS: (574) 4448438 Ext 108 (Monday to Friday) 6:30 am to 4:30 pm (UTC/GMT 5 hours)
Inactive Ingredients
glycerin, water. citric acid, propanediol
* Please review the disclaimer below.