ANTI-BACTERIAL HAND SANITIZER- anti-bacterial hand sanitizer liquid
Dongguan Benoy Industrial 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 Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

Hand sanitizer to help decrease bacteria on the skin when water, soap &u to we 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 in use of this product.

Directions

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

Other information

Do not store in temperature over 118F

Inactive ingredients

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

Package Label - Principal Display Panel

ANTI-BACTERIAL HAND SANITIZER
anti-bacterial hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75387-501
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
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75387-501-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/19/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/19/2020	01/21/2021

Labeler - Dongguan Benoy Industrial CO.,LTD (403972510)

Name	Address	ID/FEI	Business Operations
Establishment
Dongguan Benoy Industrial CO.,LTD		403972510	manufacture(75387-501)

Revised: 1/2021

Document Id: b963d83b-584e-c447-e053-2995a90ad973

Set id: a60c5ff5-b8f4-1f0b-e053-2995a90a67a3

Version: 2

Effective Time: 20210121

Dongguan Benoy Industrial CO.,LTD