H2 365 CLEAN: Package Insert and Label Information

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.

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
(click image for full-size original)

H2 365 CLEAN
glycerin soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73269-0001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
COCONUT OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73269-0001-1 70 g in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part347 09/14/2019
Labeler — IRISTA (689523945)
Registrant — IRISTA (689523945)
Establishment
Name Address ID/FEI Operations
IRISTA 689523945 manufacture (73269-0001), label (73269-0001)

Revised: 09/2019 IRISTA

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