BESAFE HAND SANITIZER- alcohol solution
Besafe Industries LLC

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

Purpose

Antiseptic

Use

For hand washing to decrease bacterial 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 then 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 adults supervision

Not reommended for infants

Other information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, carbomer, triethanolamine, glycerin, aloe barbadensis gel, propylene glycol, tocopheryl acetate (Vitamin E)

image description

BESAFE HAND SANITIZER
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77693-001
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
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77693-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2020
2	NDC:77693-001-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2020
3	NDC:77693-001-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2020
4	NDC:77693-001-04	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2020
5	NDC:77693-001-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2020
6	NDC:77693-001-06	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2020
7	NDC:77693-001-07	1800 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2020
8	NDC:77693-001-08	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/14/2020

Labeler - Besafe Industries LLC (117481216)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Shenying Technology Co., Ltd. Jiaojiang Branch		414137820	manufacture(77693-001)