HAND SANITIZER- ethyl alcohol gel 
Nantong Health & Beyond Hygienic Products 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 62% v/v

Purpose
Antiseptic

Use[s]

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.

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 1 – 30°C (59- 86°F)

• Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Water (Aqua), Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Denatonium Benzoate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Maltodextrin.

image of bottle label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43473-262
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43473-262-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/08/2020
Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)
Registrant - Nantong Health & Beyond Hygienic Products Inc. (421280161)

Revised: 6/2020
Document Id: a78d7e04-cfa6-94f0-e053-2a95a90a7c35
Set id: a78d7e04-cfa5-94f0-e053-2a95a90a7c35
Version: 1
Effective Time: 20200608
 
Nantong Health & Beyond Hygienic Products Inc.