Active Ingredient
Glycerin
All-in-one Cleanser
FDA Label NDC 80453-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by O2 Clean for the product All-in-one Cleanser (NDC 80453-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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