Label: CICATRIX SKIN PROTECTANT- glycerin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64539-005-01, 64539-005-02 - Packager: Catalysis, SL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 28, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS PURPOSE
- Warnings
- Questions or comments?
- Other Information
- Directions
- Uses
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Inactive Ingredients
Aqua, Cyclopentasiloxane, Cetearyl Alcohol, PPG-11 Stearyl Ether, Steareth-2, Ceramide 3, Ceramide 6II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Centella Asiatica Leaf Extract, Maltodextrin, Stearic Acid, Palmitic Acid, Phenoxyethanol, Ethylhexylglycerin, C12-C15 Alkyl Benzoate, Steareth-20, Pinus Sylvestris Bud Extract, Sodium Benzoate, Potassium Sorbate, Sodium Hyaluronate, Carbomer, Diazolydinil Urea, Parfum( coumarin, hexyl cinnamal,linalool,d-limonene/dipentene/l-limonene,Geraniol,hydroxycitronellal), Sodium Hydroxide
- Uses
- Package Label
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INGREDIENTS AND APPEARANCE
CICATRIX SKIN PROTECTANT
glycerin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64539-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength COUMARIN (UNII: A4VZ22K1WT) 0.1 mg in 1 mL HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.2 mg in 1 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.12 mg in 1 mL PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) 0.12 mg in 1 mL PPG-11 STEARYL ETHER (UNII: S4G2J0Y0LG) 3 mg in 1 mL STEARETH-2 (UNII: V56DFE46J5) 2.4 mg in 1 mL CERAMIDE 3 (UNII: 4370DF050B) 0.25 mg in 1 mL PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) 0.25 mg in 1 mL CERAMIDE 6 II (UNII: F1X8L2B00J) 0.25 mg in 1 mL CHOLESTEROL (UNII: 97C5T2UQ7J) 0.25 mg in 1 mL SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) 0.25 mg in 1 mL WATER (UNII: 059QF0KO0R) 100 mg in 1 mL CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.45 mg in 1 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.25 mg in 1 mL CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 3 mg in 1 mL CENTELLA ASIATICA LEAF (UNII: 6810070TYD) 0.5 mg in 1 mL STEARIC ACID (UNII: 4ELV7Z65AP) 0.5 mg in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.5 mg in 1 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.5 mg in 1 mL ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) 0.8 mg in 1 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.07 mg in 1 mL STEARETH-20 (UNII: L0Q8IK9E08) 0.6 mg in 1 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.14 mg in 1 mL CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 7 mg in 1 mL DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) 0.2 mg in 1 mL MALTODEXTRIN (UNII: 7CVR7L4A2D) 0.5 mg in 1 mL PALMITIC ACID (UNII: 2V16EO95H1) 0.5 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64539-005-02 1 in 1 BOX 05/02/2017 1 NDC:64539-005-01 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/02/2017 Labeler - Catalysis, SL (862795119) Registrant - Catalysis, SL (862795119) Establishment Name Address ID/FEI Business Operations Catalysis, SL 862795119 manufacture(64539-005)
