PROTECTION HP HAND SANITIZERGEL- hand sanitizergel gel 
Shenzhen Anmay Paper Manufacture Co., Ltd.

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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Store in a cool and dry place

Water

Place enough gel into your palm to thoroughly spread on both hands (front & back) and rub into the skin until dry.Children should be supervised when using this product.

carbomer

triethanolamine

ethanol

keep out of reach of children

Disinfection
Sterilization
No Rinseing

For external use only. Do not use in or near the eyes.In case of contact with eyes, flush thoroughly with water. Do not swallow. If swallowed, seek medical help or contact a Poison Control Center immediately. Avoid contact with broken skin. Seek medical help if iritation or redness develops and condition continues for more than 72 hours. KEEP OUT OF REACH OF CHILDREN. Can be used
on children under adult supervision. Not recommended for infants.

label

PROTECTION HP HAND SANITIZERGEL 
hand sanitizergel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54306-003
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL375 mL  in 500 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) (CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - UNII:0A5MM307FC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE1.5 g  in 500 mL
TROLAMINE (UNII: 9O3K93S3TK) (TROLAMINE - UNII:9O3K93S3TK) TROLAMINE1.4 g  in 500 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.5 g  in 500 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code PROTECTIONHP
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54306-003-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/20/2020
Labeler - Shenzhen Anmay Paper Manufacture Co., Ltd. (543063167)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen Anmay Paper Manufacture Co., Ltd.543063167manufacture(54306-003)

Revised: 7/2020
Document Id: aa10d28a-673c-45c4-e053-2995a90a8ed2
Set id: a6114c85-b4ad-f807-e053-2995a90ad3b4
Version: 2
Effective Time: 20200710
 
Shenzhen Anmay Paper Manufacture Co., Ltd.