CHAMOSYN PARABEN FREE- barrier cream ointment ointment 
Bershtel Enterprises LLC

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.

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Menthol 0.45% or 0.1%Zinc oxide 20%

Anorectal analgesic/Anti-itchSkin protectant

Helps relieve the local discomfort, burning, and itching of the perianal area associated with anorectal disorders and inflamed hemorrhoidal tissues.Aids in protecting irritated anorectal areas.Dries the oozing and weeping of poisonivyoaksumac

Anorectal analgesic/Anti-itch Skin protectant

Helps relieve the local discomfort, burning, and itching of the perianal area associated with anorectal disorders and inflamed hemorrhoidal tissues. Aids in protecting irritated anorectal areas.Dries the oozing and weeping of poison ivy oak sumac

Topical

For external use only.When using this productdo not get into eyesStop use and ask a doctor ifcondition worsenssymptoms do not improve within 7 days or clear up and occur again within a few days.Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using fingers or any medical device or applicator. Certain persons can develop allergic reactions to this product. If symptoms do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with clean tissue or a clean soft cloth before application of this product.Children under 12 years of age: consult a doctor.Apply externally to the affected area as needed up to 6 times daily or after each incontinence episode or diaper change.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

ChamosynActive aloe gel, Calamine, Chamomilla recutita (matricaria) flower extract, Cod liver oil, Disodium EDTA, Glycerin, Lanolin, Light mineral oil, Manuka honey, Methylparaben, Microcrystalline wax, Petrolatum, Propylparaben, Sodium borate, Sorbitan oleate, Tocopherol, WaterChamosyn - Paraben FreeActive aloe gel, Calamine, Caprylyl glycol, Chamomilla recutita (matricaria) flower extract, Cod liver oil, Disodium EDTA, Ethylhexylglycerin, Glycerin, Lanolin, Light mineral oil, Manuka honey, Microcrystalline wax, Petrolatum, Phenoxyethanol, Sodium borate, Sorbitan oleate, Tocopherol, Water

For questions call (888) 425-1149

Consumer BoxPacket

CHAMOSYN PARABEN FREE 
barrier cream ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10564-0030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.5 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM BORATE (UNII: 91MBZ8H3QO)  
CHAMOMILE (UNII: FGL3685T2X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
COD LIVER OIL (UNII: BBL281NWFG)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
HONEY (UNII: Y9H1V576FH)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
LANOLIN (UNII: 7EV65EAW6H)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10564-0030-11 in 1 BOX01/01/2016
1NDC:10564-0030-05 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/01/2016
Labeler - Bershtel Enterprises LLC (066659129)

Revised: 1/2018
 
Bershtel Enterprises LLC