D.therapino One Step Hand Sanitizer: Package Insert and Label Information

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.

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
(click image for full-size original)

D.THERAPINO ONE STEP HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58241-0008
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
MENTHOL
CARBOMER 940
TROLAMINE
WATER
ALOE VERA LEAF
1,2-HEXANEDIOL
BUTYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58241-0008-1 3785 mL in 1 BOTTLE None
2 NDC:58241-0008-2 1000 mL in 1 BOTTLE None
3 NDC:58241-0008-3 110 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/13/2020
Labeler — David Cosmetic Co Ltd (695697845)
Registrant — David Cosmetic Co Ltd (695697845)
Establishment
Name Address ID/FEI Operations
David Cosmetic Co Ltd 695697845 manufacture (58241-0008), label (58241-0008)

Revised: 06/2020 David Cosmetic Co Ltd

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