HAND CLEANER 7: Package Insert and Label Information

HAND CLEANER 7- alcohol gel
Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch

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

sterilization of hands, skin and so on

KEEP OUT OF REACH OF THE CHILDREN

take appropriate amount on the hand, rub and dry well

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

for external use only

glycerin, carbomer, trolamine, water, lemon fragrance

label
(click image for full-size original)

HAND CLEANER 7
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75695-0002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE
WATER
ALOE VERA LEAF
CARBOMER 940
LEMON OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75695-0002-1 500 mL in 1 BOTTLE None
2 NDC:75695-0002-2 300 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/01/2020
Labeler — Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch (695625894)
Registrant — Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch (695625894)
Establishment
Name Address ID/FEI Operations
Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch 695625894 manufacture (75695-0002)

Revised: 04/2020 Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch

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