H2 365 CLEAN- glycerin soap
IRISTA

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

coconut oil powder, silver, raisinseed oil, avocado oil, plumseed oil

skin protectant

keep out of reach of the children

apply to the skin and wash away with clean water

do not use if yu have skin problems

if red spots, swelling or itching occur during use, discontinue use

if gets in your eyes, wash with clean water

for external use only

label

H2 365 CLEAN
glycerin soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73269-0001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
COCONUT OIL (UNII: Q9L0O73W7L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73269-0001-1	70 g in 1 PACKAGE; Type 0: Not a Combination Product	09/14/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part347	09/14/2019

Labeler - IRISTA (689523945)

Registrant - IRISTA (689523945)

Name	Address	ID/FEI	Business Operations
Establishment
IRISTA		689523945	manufacture(73269-0001) , label(73269-0001)

Revised: 9/2019

Document Id: 92a5b7b4-1b4b-57f4-e053-2995a90afb9d

Set id: 92a59e62-77f5-b755-e053-2a95a90af2fd

Version: 1

Effective Time: 20190916

IRISTA