BESAFE- hand sanitizer 75% alcohol gel
Zhejiang Guoyao Jingyue Aerosol 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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Besafe Hand Sanitizer

Active Ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use

for hand washing to decrease bacteria on the skin.

Warnings

For external use only. Flammable, keep away from fire and flame.

Do not use in the eyes.

Stop use and ask a doctor if:

Irritation and redness develop.
condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.
for children under 6, use only under adult supervision.
not recommended for infants.

Other information

Do not store above 105 oF

May discolor some fabrics
Harmful to wood finishes & plastic

Inactive Ingredients

Water, Glycerin, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Tocopherol

label

BESAFE
hand sanitizer 75% alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75742-011
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75742-011-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
2	NDC:75742-011-02	53 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
3	NDC:75742-011-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
4	NDC:75742-011-04	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
5	NDC:75742-011-05	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
6	NDC:75742-011-06	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
7	NDC:75742-011-07	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/07/2020
8	NDC:75742-011-08	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/07/2020
9	NDC:75742-011-09	375 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/07/2020
10	NDC:75742-011-10	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/07/2020
11	NDC:75742-011-11	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/07/2020
12	NDC:75742-011-12	1200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/07/2020
13	NDC:75742-011-13	1800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/07/2020

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

Labeler - Zhejiang Guoyao Jingyue Aerosol Co., Ltd. (554529812)

Registrant - Zhejiang Guoyao Jingyue Aerosol Co., Ltd. (554529812)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Guoyao Jingyue Aerosol Co., Ltd.		554529812	manufacture(75742-011)