P9 PHOTO CLEANSER by General Bio Co., Ltd. Drug Facts

P9 PHOTO CLEANSER by

Drug Labeling and Warnings

P9 PHOTO CLEANSER by is a Otc medication manufactured, distributed, or labeled by General Bio Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

P9 PHOTO CLEANSER- glycerin solution 
General Bio 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.

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Drug Facts

glycerin

water, ethanol, sodium citrate, aminolevulinic acid hcl

skin protectant

keep out of reach of the children

apply proper amount to the skin and massage and wash away with warm water

・Stop using the product when you have skin problems or the product disagrees with your skin
・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
・If the product gets into the eyes, don't rub but rinse with water.
・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.

for external use only

P9 PHOTO CLEANSER 
glycerin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69422-4001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	69.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
AMINOLEVULINIC ACID HYDROCHLORIDE (UNII: V35KBM8JGR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69422-4001-1	1.1 mL in 1 SYRINGE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/08/2014	09/30/2019

Labeler - General Bio Co., Ltd. (688299527)

Registrant - General Bio Co., Ltd. (688299527)

Establishment
Name	Address	ID/FEI	Business Operations
General Bio Co., Ltd.		688299527	manufacture(69422-4001)

Revised: 10/2019

Document Id: 962621d1-da42-3160-e053-2995a90ad0fa

34390-5

Set id: c5fe26fe-2a2d-4b8a-b7aa-d279c56ce5fa

Version: 3

Effective Time: 20191030

 

General Bio Co., Ltd.