WHITE ORGANIA FRESH PURE HAND SANITIZER: Package Insert and Label Information

WHITE ORGANIA FRESH PURE HAND SANITIZER- alcohol gel
WHITE COSPHARM 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.

500

WHITE ORGANIA FRESH PURE HAND SANITIZER
ethanol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75312-0500
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 350 mL in 500 mL
Inactive Ingredients
Ingredient Name Strength
AMINOMETHYLPROPANOL
POLYSORBATE 20
GRAPEFRUIT
EDETATE DISODIUM
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
WATER
BUTYLENE GLYCOL
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75312-0500-1 500 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 04/17/2020
Labeler — WHITE COSPHARM CO.,LTD. (688442259)
Establishment
Name Address ID/FEI Operations
WHITE COSPHARM CO.,LTD. 688442259 manufacture (75312-0500)

Revised: 04/2020 WHITE COSPHARM CO.,LTD.

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