Label: CHAMOSYN PARABEN FREE- barrier cream ointment
CHAMOSYN- barrier cream ointment
- NDC Code(s): 51028-002-01, 51028-003-00, 51028-003-01
- Packager: Links Medical Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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 Label Information
Updated October 13, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
-
Warnings
For external use only.
When using this product
- do not get into eyes
Stop use and ask a doctor if
- condition worsens
- symptoms 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.
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- 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.
- Other information
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Inactive Ingredients
Chamosyn
Active 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, Water
Chamosyn - Paraben Free
Active 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
- Questions?
- Chamosyn Ointment (0.45% Menthol)
- Chamosyn Ointment (0.45% Menthol) - Paraben Free
- Chamosyn Ointment (0.1% Menthol)
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INGREDIENTS AND APPEARANCE
CHAMOSYN PARABEN FREE
barrier cream ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51028-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.5 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) FERRIC OXIDE RED (UNII: 1K09F3G675) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHAMOMILE (UNII: FGL3685T2X) COD LIVER OIL (UNII: BBL281NWFG) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) LIGHT MINERAL OIL (UNII: N6K5787QVP) HONEY (UNII: Y9H1V576FH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PETROLATUM (UNII: 4T6H12BN9U) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM BORATE (UNII: 91MBZ8H3QO) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) Product Characteristics Color pink Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51028-003-00 144 in 1 BOX 01/01/2016 1 5 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:51028-003-01 113 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2016 CHAMOSYN
barrier cream ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51028-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength SODIUM BORATE (UNII: 91MBZ8H3QO) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) FERRIC OXIDE RED (UNII: 1K09F3G675) CHAMOMILE (UNII: FGL3685T2X) COD LIVER OIL (UNII: BBL281NWFG) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) LIGHT MINERAL OIL (UNII: N6K5787QVP) HONEY (UNII: Y9H1V576FH) METHYLPARABEN (UNII: A2I8C7HI9T) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PETROLATUM (UNII: 4T6H12BN9U) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color pink Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51028-002-01 113 g in 1 TUBE; Type 0: Not a Combination Product 01/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/15/2015 Labeler - Links Medical Products (839081445) Registrant - Westwood Laboratories, LLC (832280635)
