HAND SANITIZER- ethyl alcohol gel 
Sutra Beauty Inc

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)

Ethyl Alcohol 75% v/v

Inactive ingredients

Aloe Barbadensis Leaf Extract, Aqua, Camellia Sinensis Leaf Oil, Carbomer, Rosmarinus Officinalis (Rosemary) Leaf Oil, Parfum.

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that can potentially cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable, keep away from fire or flame.

Do not use

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

Irritation or rash occurs. These may be signs of a serious condition.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Other information

Questions or Comments?

Call 1-888-463-6332 Monday-Friday 9AM-5PM EST FDA NDC Product Code: 76741-003-12

Package Label - Principal Display Panel

120 ml NDC:76741-003-12 Lavender Label ALavender Label B

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76741-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TEA LEAF OIL (UNII: VC855RRT77)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76741-003-12120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/19/2020
Labeler - Sutra Beauty Inc (040228928)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Joy Claire Biological Technology Co.,Ltd418209894manufacture(76741-003)

Revised: 12/2020
Document Id: b7a21773-cafb-2960-e053-2995a90ada31
Set id: ad4287fe-2b10-4a40-e053-2995a90a6340
Version: 3
Effective Time: 20201229
 
Sutra Beauty Inc