HAND SANITIZER- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by KLM Promo Products, LLC, JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

1. 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.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. 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 62%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Decrease bacteria and germs on the hands
when water, soap, and towel are not available
recommended for repeated use

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

Do not use in ears and mouth

WHEN USING

When using this product avoid contact with eyes. In case of contact flush eyes with water.

STOP USE

Stop use and ask a doctor if irritation or redness develops or persists.

KEEP OUT OF REACH OF CHILDREN

Children under 6, use only under adult supervision. Not recommended for infants.

Directions

• pump as needed on to your palms and thoroughly spread on both hands
• rub into skin until dry

Other information

• store at 20℃(68℉-77℉)
• may discolor fabrics

Inactive ingredients

Purified Water, Triethanolamine, Glycerin, Disodium EDTA, carbomer

Package Label - Principal Display Panel

30 mL NDC: 77165-300-01

antibacterial hand sanitizer

1 fl.oz. (30ml)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77165-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 1N11AG4X4L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77165-300-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 77165-300-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - KLM Promo Products, LLC (017087764)

Registrant - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)