HAND SANITIZER NON-STERILE solution

HAND SANITIZER NON-STERILE by

Drug Labeling and Warnings

HAND SANITIZER NON-STERILE by is a Otc medication manufactured, distributed, or labeled by Guangzhou Shiruoni Cosmetics Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not avallable.

WARNING

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

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

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

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.

Other information

Store between 15-30C(59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

deionized water, aloe barbadensis extract, carbomer, arginine, silver ions

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER NON-STERILE 
hand sanitizer non-sterile solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75605-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ARGININE (UNII: 94ZLA3W45F)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
SILVER CATION (UNII: 57N7B0K90A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75605-008-03	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
2	NDC: 75605-008-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
3	NDC: 75605-008-02	252 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020
4	NDC: 75605-008-04	500 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
Guangzhou Shiruoni Cosmetics Co.,Ltd		551125378	manufacture(75605-008)