FDA Label for Sunmitte Hand Sanitizer
View Indications, Usage & Precautions
Sunmitte Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Henan Shizheng Pharmaceutical Technology Co., Ltd.. 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 (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerin(3% v/v).
- Carbomer(0.8% v/v).
- Trolamine(0.2% 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
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 and lasts.
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
- Apply enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.
- Children under age 6 should be supervised when using this product.
Other Information
- Store between 1-30C (33.8-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
glycerin, carbomer, water, Trolamine
Package Label - Principal Display Panel
59 ml NDC: 75138-120-06
100 ml NDC: 75138-120-10
300 ml NDC: 75138-120-30
500 ml NDC: 75138-120-50
500 ml NDC: 75138-120-51
500 ml NDC: 75138-120-52
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