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Parma Anus Skin Premium Cleanser

Dosage form: gel
Ingredients: ALLANTOIN 3mg in 1mL
Labeler: PARMA KOREA.CO.LTD
NDC Code: 71614-002

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Facts

Allantoin 0.3%

Skin Protectant

Anus Cleansing

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.

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.

Keep out of reach of children

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

PARMA ANUS SKIN PREMIUM CLEANSER 
allantoin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71614-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
MANDELIC ACID 
EDETATE DISODIUM ANHYDROUS 
OLEIC ACID 
LAURYL GLUCOSIDE 
BUTYLENE GLYCOL 
DIGLYCERIN 
SODIUM COCOATE 
COCO MONOISOPROPANOLAMIDE 
NEPIDERMIN 
ACETYL HEXAPEPTIDE-8 
SODIUM COCOAMPHOACETATE 
RICE BRAN 
ARTEMISIA VULGARIS ROOT 
MUNG BEAN 
CENTELLA ASIATICA 
PURSLANE 
RHEUM PALMATUM ROOT 
BAMBUSA VULGARIS TOP 
EUCALYPTUS GLOBULUS LEAF 
HAMAMELIS VIRGINIANA TOP 
MATRICARIA CHAMOMILLA FLOWERING TOP 
PROPOLIS WAX 
SAPINDUS MUKOROSSI FRUIT 
ASIAN GINSENG 
POLYSORBATE 85 
1,2-HEXANEDIOL 
MEDIUM-CHAIN TRIGLYCERIDES 
Packaging
#Item CodePackage Description
1NDC:71614-002-021 BOTTLE in 1 CARTON
1NDC:71614-002-01100 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/25/2017
Labeler - PARMA KOREA.CO.LTD (694857393)
Registrant - PARMA KOREA.CO.LTD (694857393)
Establishment
NameAddressID/FEIOperations
PARMA KOREA.CO.LTD694857393manufacture(71614-002)

Revised: 07/2017
 
PARMA KOREA.CO.LTD

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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