D.THERAPINO ONE STEP HAND SANITIZER- alcohol gel 
David Cosmetic 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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Drug Facts

alcohol

water, aloe extract, carbomer, menthol, triethanolamine, butylene glycol, 1,2-hexanediol

KEEP OUT OF REACH OF THE CHILDREN

hand sanitizer to help reduce bacteria that potentially can cause disease

for use when soap and water are not available

hand sanitizer to help reduce bacteria that potentially can cause disease

for use when soap and water are not available

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

for external use only

label

D.THERAPINO ONE STEP HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58241-0008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58241-0008-13785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/13/2020
2NDC:58241-0008-21000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/13/2020
3NDC:58241-0008-3110 mL in 1 TUBE; Type 0: Not a Combination Product06/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/13/2020
Labeler - David Cosmetic Co Ltd (695697845)
Registrant - David Cosmetic Co Ltd (695697845)
Establishment
NameAddressID/FEIBusiness Operations
David Cosmetic Co Ltd695697845manufacture(58241-0008) , label(58241-0008)

Revised: 6/2020
Document Id: a7edc13c-bd4b-46a8-e053-2995a90abafc
Set id: a7edc96f-895b-1a11-e053-2995a90affe3
Version: 1
Effective Time: 20200612
 
David Cosmetic Co Ltd