ANTI-BACTERIAL HAND SANITIZER- anti-bacterial hand sanitizer liquid
Dongguan Beinuoer Industry 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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ANTI-BACTERIAL HAND SANITIZER

Active Ingredients

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

Hand sanitizer to help decrease bacteria on the skin when water, soap & towe are not available Recommend for repeated use

Warnings

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

Do not use

Do not apply around eyes
Do not use in ears or mouth

When using this product, avoid contact with eyes.In case of contact, flush eyes with water.

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours

Keep out of reach of children. Children must be supervised inuse of this product.

Directions

Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry

Other information

Do not store in temperature over 118 F

Inactive ingredients

Water, Glycerin
Propylene glycol ,Carbomer. Triethanolamine,Aloe Barbadensis Leaf Juice.

Package Label - Principal Display Panel

250ml

ANTI-BACTERIAL HAND SANITIZER
anti-bacterial hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75387-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
CARBOMER 934 (UNII: Z135WT9208)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75387-005-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/22/2020	01/21/2021

Labeler - Dongguan Beinuoer Industry Co., Ltd. (403972510)

Name	Address	ID/FEI	Business Operations
Establishment
Dongguan Bocheng Industry Investment Co., Ltd.		418842686	manufacture(75387-005)

Revised: 1/2021

Document Id: b96395f9-b24b-7e56-e053-2a95a90a8c80

Set id: a3da2f00-e5dc-c716-e053-2a95a90a7519

Version: 2

Effective Time: 20210121

Dongguan Beinuoer Industry Co., Ltd.