ATOPIM- fermented enxyme extract of aloe. glycerin liquid
HI Technology

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.

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Drug Facts

aloe, glycerin

butylene glycol, water, niacinamide, adlay fermented extract, etc

improve on acne, stopic dermatitis, and effects on burn treatment, skin soothing

keep out of reach of the children

after cleansing thoroughly, moisten 1~2g in cotton or sterilized gauze and attached to the affected area for 20~30 minutes to absorb enough contents

do not swallow it

do not use on wounded skin

do not use allergic skin types

for topical use only

label

ATOPIM
fermented enxyme extract of aloe. glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73158-0001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2.5 g in 100 g
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	64 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73158-0001-1	100 g in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part347	05/11/2019

Labeler - HI Technology (695708203)

Registrant - The Times Co., Ltd. (695708203)

Name	Address	ID/FEI	Business Operations
Establishment
HI Technology		695708203	manufacture(73158-0001)

Revised: 6/2019

Document Id: 8b00e806-89d2-7385-e053-2a95a90a718c

Set id: 8b01b776-cc0f-7d85-e053-2995a90ae626

Version: 1

Effective Time: 20190610

HI Technology