HAND SANITIZER- alcohol hand sanitizer gel 
Henry Rose 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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Drug Facts

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

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

Other information

Inactive ingredients

WATER (AQUA), GLYCERIN, FRAGRANCE, CARBOMER, ALOE BARBADENSIS LEAF JUICE, SODIUM HYDROXIDE, LINALOOL

Package Label - Principal Display Panel

200 mL NDC: 80006-070-02

LABEL

HAND SANITIZER 
alcohol hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80006-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80006-070-02200 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/15/2020
Labeler - Henry Rose LLC (117413381)

Revised: 3/2021
Document Id: bd95b422-9e16-947f-e053-2a95a90a17b8
Set id: bd95c6d6-60df-9477-e053-2a95a90a95f2
Version: 1
Effective Time: 20210315
 
Henry Rose LLC