LABCCIN Fresh Sanitizer Gel: Package Insert and Label Information

LABCCIN FRESH SANITIZER GEL- alcohol gel
BIOSTECH 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.

LABCCIN Fresh Sanitizer Gel
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LABCCIN FRESH SANITIZER GEL
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70812-500
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 345 mL in 500 mL
Inactive Ingredients
Ingredient Name Strength
PAEONIA LACTIFLORA ROOT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
ANGELICA GIGAS WHOLE
BETULA PLATYPHYLLA VAR. JAPONICA BARK
GLYCERIN
CLOVE
WATER
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70812-500-01 500 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 05/18/2020
Labeler — BIOSTECH CO., LTD. (687294330)
Establishment
Name Address ID/FEI Operations
BIOSTECH CO., LTD. 687294330 manufacture (70812-500)

Revised: 05/2020 BIOSTECH CO., LTD.

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