Label: MEDERMA PM- dimethicone cream
- NDC Code(s): 0259-2202-28, 0259-2202-48
- Packager: Merz Pharmaceuticals, LLC
- 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 February 23, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
- Warnings
- Directions
- Other Information
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Inactive Ingredients
Water, Cetearyl Alcohol, Glycerin, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Pentylene Glycol, Cyclomethicone, Arachidyl Alcohol, Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Allium Cepae (Onion) Bulb Extract, Copper Tripeptide-1, Aloe Barbadensis Leaf, Cetearyl Glucoside, Tocopherol Acetate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Hydrolyzed Soy Protein, Glycine, Panthenol, Hydrolyzed Collagen, PEG-400, Arginine HCL, Leucine, Lysine Hydrochloride, Alanine, Sodium Lactate, Aspartic Acid, Glucose, Glutamic Acid, Isopropyl Alcohol, Mannitol, Sorbitol, Tromethamine, Valine, Histidine Hydrochloride, Isoleucine, Phenylalanine, Tyrosine, Potassium Sorbate, Sodium Benzoate, Citric Acid, Sodium Hydroxide, Fragrance.
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- PRINCIPAL DISPLAY PANEL - 48 g Jar Carton
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INGREDIENTS AND APPEARANCE
MEDERMA PM
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0259-2202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 20 mg in 1 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Onion (UNII: 492225Q21H) Cetostearyl Alcohol (UNII: 2DMT128M1S) Glycerin (UNII: PDC6A3C0OX) Dicaprylyl Carbonate (UNII: 609A3V1SUA) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Pentylene Glycol (UNII: 50C1307PZG) Cyclomethicone (UNII: NMQ347994Z) Arachidyl alcohol (UNII: 1QR1QRA9BU) Alcohol (UNII: 3K9958V90M) Docosanol (UNII: 9G1OE216XY) Arachidyl glucoside (UNII: 6JVW35JOOJ) Cetearyl Glucoside (UNII: 09FUA47KNA) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Hydroxyethyl acrylate/Sodium acryloyldimethyl Taurate Copolymer (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) Hydroxyethyl Cellulose (2000 MPA.S AT 1%) (UNII: S38J6RZN16) Sodium Hydroxide (UNII: 55X04QC32I) Aloe Vera Leaf (UNII: ZY81Z83H0X) Glycine (UNII: TE7660XO1C) Panthenol (UNII: WV9CM0O67Z) Bovine Type I Collagen (UNII: FHJ3ATL51C) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Potassium Sorbate (UNII: 1VPU26JZZ4) Sodium Benzoate (UNII: OJ245FE5EU) Citric Acid Monohydrate (UNII: 2968PHW8QP) Arginine Hydrochloride (UNII: F7LTH1E20Y) Leucine (UNII: GMW67QNF9C) Lysine Hydrochloride (UNII: JNJ23Q2COM) Alanine (UNII: OF5P57N2ZX) Sodium Lactate (UNII: TU7HW0W0QT) Aspartic Acid (UNII: 30KYC7MIAI) Dextrose, unspecified form (UNII: IY9XDZ35W2) Glutamic Acid (UNII: 3KX376GY7L) Isopropyl Alcohol (UNII: ND2M416302) Mannitol (UNII: 3OWL53L36A) Sorbitol (UNII: 506T60A25R) Tromethamine (UNII: 023C2WHX2V) Valine (UNII: HG18B9YRS7) Prezatide Copper (UNII: 6BJQ43T1I9) Soy Protein (UNII: R44IWB3RN5) Histidine Monohydrochloride (UNII: 1D5Q932XM6) Isoleucine (UNII: 04Y7590D77) Phenylalanine (UNII: 47E5O17Y3R) Tyrosine (UNII: 42HK56048U) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0259-2202-28 1 in 1 BOX 11/01/2013 07/31/2024 1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0259-2202-48 1 in 1 BOX 11/01/2013 04/30/2023 2 48 g in 1 JAR; 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 11/01/2013 07/31/2024 Labeler - Merz Pharmaceuticals, LLC (126209282)