OTC Medication Information: WellDerma CLEAN HAND SANITIZER Gel

WELLDERMA CLEAN HAND SANITIZER GEL- alcohol gel
PPU 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, etc

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

keep out of reach of the children

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.

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 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.

for external use only

label
(click image for full-size original)

WELLDERMA CLEAN HAND SANITIZER GEL
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74999-0002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 310 mL in 500 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 60
TROLAMINE
BUTYLENE GLYCOL
WATER
ISOPROPYL MYRISTATE
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74999-0002-2 500 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/10/2020
Labeler — PPU CO., LTD (690420457)
Registrant — PPU CO., LTD (690420457)
Establishment
Name Address ID/FEI Operations
Ester Co., Ltd. 688425766 manufacture (74999-0002)
Establishment
Name Address ID/FEI Operations
PAMTEK COSMETIC Co., Ltd 690420457 label (74999-0002)

Revised: 01/2021 PPU CO., LTD

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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