62% ALCOHOL HAND SANITIZER- hand sanitizer gel 
Ultra Distributors 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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Disinfection
Sterilization
No Rinseing

Alcohol62%

Directions: Pour a sufficient amount of the liquid into the palm of your dry hands. Rub thoroughly all over hands briskly until dry. Repeat if necessary. Use without water. Use only under adult supervision.

Warnings: Highly flammable liquid and vapour. Causes serious eye iritation. May cause skin iritation. Keep away from heat, sparks, hot surfaces, fire, open flame and sources of ignition. No smoking. Keep at room temperature. Store in a well-ventilated, cool and dry place, away from direct sunlight. Do not store above 40 °C

For external use only.

Avoid contact with eyes. If in eyes, rinse immediately with clean water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Do not swallow. If swallowed, rinse mouth and seek medical advice immediately and show this label. Do not induce vomiting. Do not use on damage, inflamed or broken skin. If iritation or redness develops, discontinue use.

Keep out of the reach of babies, children & animals.

236ml store in ventilated shade and Do not store above 40 °C

Alcohol, water/eau/aqua, carbomer,triethanolamine, propylene glycol, glycerin

Front Panel and Back Panel Art

label

62% ALCOHOL HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78495-015
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL146.32 mL  in 236 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78495-015-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/07/2020
Labeler - Ultra Distributors Inc (007160073)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Distributors007160073relabel(78495-015)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Home Solution Corp., LTD679868836manufacture(78495-015)

Revised: 12/2021
Document Id: d3d7b17e-d243-7ccb-e053-2a95a90addfd
Set id: a838bab3-67be-213f-e053-2a95a90ab2d5
Version: 2
Effective Time: 20211223
 
Ultra Distributors Inc