HAND SANITIZER- alcohol antiseptic gel 
Goodier Cosmetics

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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Hand Sanitizer

Active ingredient Alcohol 70% w/w

Purpose Antiseptic

Uses 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 15-30C (59-86F) • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients Aminomethyl Propanol, t-Butyl Alcohol, Carbomer, Denatonium Benzoate, Fragrance (Parfum), Glycerin, Water (Aqua)

Revision Hand Sanitizer Label

Revision Label

Goodier Hand Sanitizer Label

Goodier Label

HAND SANITIZER 
alcohol antiseptic gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10477-2630
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.1 mL  in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.09 mL  in 100 mL
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.3 mL  in 100 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) 0.0004 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 3.4 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 18.8 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10477-2630-11 in 1 BOTTLE, PLASTIC06/08/2020
11 in 1 NOT APPLICABLE
159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/08/2020
Labeler - Goodier Cosmetics (007317209)
Establishment
NameAddressID/FEIBusiness Operations
Goodier Cosmetics007317209manufacture(10477-2630)

Revised: 12/2022
Document Id: f05be646-5011-a071-e053-2a95a90ac79c
Set id: a82c2388-2eb5-44f2-a962-9723ed652010
Version: 3
Effective Time: 20221221
 
Goodier Cosmetics