HAND SANITIZER- alcohol gel
TRANG LY PHARMA TRADE COMPANY LIMITED
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.
Alcohol 80% v/v. Purpose: Antiseptic
Dry Hand Sanitizer helps prevent the development of bacteria on the skin.
It moisturizes and softens the hand skin with the sweet fragrance.
For external use only. Flammable. Keep away from heat or flame
- for children under 36 months.
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
For children: need to be supervised by adults when using it.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
- 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.
- Store in dry and cool place
glycerin, hydrogen peroxide, purified water USP
Keep our of reach of children
100 mL NDC: 90098-100-01
250 mL NDC: 90098-100-02
500 mL NDC: 90098-100-03
1000 mL NDC: 90098-100-04
2000 mL NDC: 90098-100-05
10000 mL NDC: 90098-100-06
20000 mL NDC: 90098-100-07
59 mL NDC: 90098-100-08
1 Gallon NDC: 90098-100-09
| HAND SANITIZER |
|Labeler — TRANG LY PHARMA TRADE COMPANY LIMITED (555252970)|
|Registrant — TRANG LY PHARMA TRADE COMPANY LIMITED (555252970)|
|TRANG LY PHARMA TRADE COMPANY LIMITED||555252970||manufacture (90098-100)|
Revised: 10/2020 TRANG LY PHARMA TRADE COMPANY LIMITED
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