Hand Sanitizer by Guangzhou Shiruoni Cosmetics Co.,Ltd / Enter Establishment Name HAND SANITIZER gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Guangzhou Shiruoni Cosmetics Co.,Ltd, Enter Establishment Name. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethanol 80%

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on skin

Directions

Place enough Product in your palm to thoroughly spread on both
hands and rub into the skin until dry.
Children under 6 years of age should be supervised when using
this product.

CAUTION WARNING

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

Other information

Store below 106°F. (41℃)
May discolor certain fabrics or surfaces.

Inactive ingredients

Glycerin (glycerol) , Hydrogen Peroxide, Purified Water.

Do not use

WHEN USING

When using this product, do not use in or near the eyes, ears, and
mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask doctor if irritation or rash appears and lasts.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75605-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75605-006-03	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
2	NDC: 75605-006-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
3	NDC: 75605-006-05	380 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
4	NDC: 75605-006-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
5	NDC: 75605-006-07	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
6	NDC: 75605-006-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
7	NDC: 75605-006-04	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/21/2020

Labeler - Guangzhou Shiruoni Cosmetics Co.,Ltd (551125378)

Establishment
Name	Address	ID/FEI	Business Operations
Enter Establishment Name		551125378	manufacture(75605-006)