ACTIVE GUARD HAND SANITIZER- alcohol gel
HOME & BODY COMPANY

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 Guard Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70%. Purpose: Antibacterial

Purpose

Antibacterial

Use

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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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.

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 (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance, Glycerin

Package Label - Principal Display Panel

133 mL front

back

ACTIVE GUARD HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73746-010
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)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73746-010-01	133 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020	10/05/2022

Labeler - HOME & BODY COMPANY (081290720)

Registrant - HOME & BODY COMPANY (081290720)

Name	Address	ID/FEI	Business Operations
Establishment
HOME & BODY COMPANY		081290720	manufacture(73746-010)

Revised: 10/2022

Document Id: ea6123c3-9dbf-6d5a-e053-2a95a90aadb3

Set id: a343e0ae-ac90-2e55-e053-2995a90a06ac

Version: 3

Effective Time: 20221006

HOME & BODY COMPANY