FDA Label for Hand Sanitizer
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE
- WARNINGS
- DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- 70 ML NDC: 77320-786-70
- 70 ML BOTTLE FRONT
- 70 ML BOTTLE BACK
- 540 ML LABEL
- 540 ML BOTTLE FRONT
- 540 ML BOTTLE BACK
- 3840 ML LABEL
- 3840 ML GALLON FRONT
- 3840 ML GALLON BACK
Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Noorani Trading Inc.. 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:
- Isopropyl Alcohol (75%, 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)
Isopropyl Alcohol 75% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
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.
Otc - Stop Use
Stop use and ask a doctor if irritation, rednedd or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep away from Children & pets.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing. If swallowed, get medical help or contact poison center right way.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
glycerin, hydrogen peroxide, purified water USP
70 Ml Ndc: 77320-786-70
70 ml NDC: 77320-786-70
70 Ml Bottle Front
70 ml NDC: 77320-786-70
70 Ml Bottle Back
70 ml NDC: 77320-786-70
540 Ml Label
540 ML NDC: 77320-786-18
540 Ml Bottle Front
540 ml NDC: 77320-786-18
540 Ml Bottle Back
540 ml NDC: 77320-786-18
3840 Ml Label
3840 ml NDC: 77320-786-01
3840 Ml Gallon Front
3840 ml NDC: 77320-786-01
3840 Ml Gallon Back
3840 ml NDC : 77320-786-01
* Please review the disclaimer below.
