Label: ALL-IN-ONE CLEANSER- glycerin gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80453-100-01 - Packager: O2 Clean
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated October 13, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALL-IN-ONE CLEANSER
glycerin gelProduct 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)
