Otc - Active Ingredient
Allantoin 0.3%
Parma Anus Skin Premium Cleanser Gel
FDA Label NDC 71614-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Parma Korea for the product Parma Anus Skin Premium Cleanser (NDC 71614-002). 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 otc - active ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, 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
Otc - Purpose
Skin Protectant
Indications & Usage
Anus Cleansing
Dosage & Administration
Wet anal area thoroughly.
Apply an appropriate amount of the product to anal area. Massage anus and maintain 30 seconds. Rinse with water for 60 seconds.
Warnings
For external use only.
Do not use on damaged or broken skin.
Rinse with water to remove.
Stop use and ask a doctor if rash or irritation occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Inactive Ingredient
Water
Hydroxyethylcellulose
Black Strap Powder
Mandelic Acid
Disodium EDTA
Oleic Acid
Lauryl Glucoside
Butylene Glycol
Diglycerin
Sodium Cocoate
Cocamide MIPA
sh-Oligopeptide-1
Acetyl Hexapeptide-8
Shea Butteramidopropyl Betaine
Sodium Cocoamphoacetate
Oryza Sativa (Rice) Bran Extract
Artemisia Vulgaris Extract
Phaseolus Radiatus Seed Extract
Centella Asiatica Extract
Portulaca Oleracea Extract
Crataegus Oxyacantha Extract
Rheum Palmatum Root Extract
Bambusa Vulgaris Extract
Eucalyptus Globulus Leaf Extract
Hamamelis Virginiana (Witch Hazel) Extract
Chamomilla Recutita (Matricaria) Flower/Leaf Extract
Propolis Extract
Sapindus Mukorossi Fruit Extract
Panax Ginseng Root Extract
Polysorbate 85
1,2-Hexanediol
Caprylic/Capric Triglyceride
Fragrance
Package Label.Principal Display Panel
Image Description (Parma)
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