ALL-IN-ONE CLEANSER- glycerin gel 
O2 Clean

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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ACTIVE INGREDIENT

Glycerin

INACTIVE INGREDIENT

Broussonetia Extract
Morus Alba Stem Extract
Disodium Laureth Sulfosuccinate
Glycyrrhiza Glabra (Licorice) Root Extract
Coco-Clucoside
Sodium Cocoyl Apple Amino Acids
Houttuynia Cordata Extract
Taraxacum Officinale (Dandelion) Leaf Extract
Phellodendron Amurense Bark Extract
Broussonetia Extract
Saururus Chinensis Extract
Eucommia Ulmoides Extract
Torilis Japonica Extract
Camellia Sinensis Leaf Extract
Olea Europaea (Olive) Fruit Oil
Paeonia Suffruticosa Root Extract
Scutellaria Baicalensis Root Extract
Panthenol
Xanthan Gum
Argania Spinosa Kernel Oil
Helianthus Annuus (Sunflower) Seed Oil
Vitis Vinifera (Grape) Seed Oil
Citric Acid
Butylene Glycol
Ethylhexylglycerin
Aroma
Silk Amino Acids
Glyceryl Caprylate
Salvia Sclarea (Clary) Oil
Melaleuca Alternifolia (Tea Tree) Leaf Oil
Cymbopogon Flexuosus Oil
Lavandula Angustifolia (Lavender) Oil
Propolis Extract

PURPOSE

Skin protectant

WARNINGS

Warnings: 1. Stop using the product and consult with your general practitioner for advice if any of the following signs or symptoms appear; rash, swelling, itching and irritation during its use 2. Do not use the product for any other purpose than vaginal cleaning. Do not use this product in eyes, nose, ears and anus. 3. In case of contacting with the cleansing gel in the eyes, immediately rinse with clean water. 4. This product is single-use disposable vaginal cleanser. Please do not reuse. 5. Consult with your general practitioner for advice if you wish to use this product during pregnancy. 6. This product does not provide contraception effects. Be aware that the contraception effects may decrease if you use this product after using spermicides like vaginal contraceptive film. 7. Do not use if the individual package or any part of the applicator has been broken or damaged.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

After pumping in an appropriate amount, lather enough and rinse thoroughly with water.

DOSAGE & ADMINISTRATION

For external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1

ALL-IN-ONE CLEANSER 
glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80453-100
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PANTHENOL (UNII: WV9CM0O67Z)  
MORUS ALBA STEM (UNII: 05Y42QCG2T)  
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80453-100-01150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34710/01/2020
Labeler - O2 Clean (694888055)
Registrant - O2 Clean (694888055)
Establishment
NameAddressID/FEIBusiness Operations
O2 Clean694888055label(80453-100) , manufacture(80453-100)

Revised: 10/2020
Document Id: b197f26b-ad5b-869c-e053-2995a90acaae
Set id: b197f25c-5e83-879a-e053-2995a90adf5c
Version: 1
Effective Time: 20201013
 
O2 Clean