Hand Sanitizer by Zhejiang USHAS Cosmetics Co.,Ltd

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zhejiang USHAS Cosmetics Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Zhejiang USHAS Cosmetics Co.,Ltd

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.

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Active ingredient(s)

Alcohol 75% v/v

Purpose

Antiseptic

Use(s)

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.

Do not use

• in children less than 2 months of age.
• on open skin wounds

When using this product

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

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.

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

water,

glycerin,

acrylates/vinyl isodecanoate crosspolymer,

aminomethyl propanol,

fragrance,

may contain: FD&C Red No.40(CI 16035), FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090), D&C Red No.33 (CI 17200).

Label

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73962-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73962-007-01	29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2020
2	NDC: 73962-007-02	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2020
3	NDC: 73962-007-03	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2020
4	NDC: 73962-007-04	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2020
5	NDC: 73962-007-05	70 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2020
6	NDC: 73962-007-06	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2020
7	NDC: 73962-007-07	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/2020	11/10/2021

Labeler - Zhejiang USHAS Cosmetics Co.,Ltd (544910474)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang USHAS Cosmetics Co.,Ltd		544910474	manufacture(73962-007)

Revised: 11/2021

Document Id: d073b7f7-77fb-fd1a-e053-2995a90ae16d

34390-5

Set id: aa70da0f-dbe7-9497-e053-2995a90accd8

Version: 3

Effective Time: 20211110