ALL-IN-ONE CLEANSER- glycerin gel

all-in-one cleanser by

Drug Labeling and Warnings

all-in-one cleanser by is a Otc medication manufactured, distributed, or labeled by O2 Clean. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ALL-IN-ONE CLEANSER 
glycerin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80453-100
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PANTHENOL (UNII: WV9CM0O67Z)
MORUS ALBA STEM (UNII: 05Y42QCG2T)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80453-100-01	150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	10/01/2020

Labeler - O2 Clean (694888055)

Registrant - O2 Clean (694888055)

Establishment
Name	Address	ID/FEI	Business Operations
O2 Clean		694888055	label(80453-100) , manufacture(80453-100)