Label: MEDERMA- avobenzone, octocrylene and oxybenzone cream

  • NDC Code(s): 0259-3192-05, 0259-3192-20, 0259-3192-50
  • Packager: Merz Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/10

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    Mederma® Cream should be evenly applied and gently rubbed into the scar 3 times daily for 8 weeks on new scars, and 3 times daily for 3–6 months on existing scars. Also apply Mederma® Cream to the scar before sun exposure.

    Children under 6 months of age: ask a doctor.

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  • Active Ingredients

    AVOBENZONE 3%, OCTOCRYLENE 10%, OXYBENZONE 6%

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  • Inactive Ingredients

    WATER, ALLIUM CEPA (ONION) BULB EXTRACT, C12-15 ALKYL BENZOATE, DICAPRYLYL CARBONATE, HYDROGENATED LECITHIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, PANTHENOL, PENTYLENE GLYCOL, PHENOXYETHANOL, BUTYROSPERMUM PARKII (SHEA BUTTER), GLYCERIN, AMMONIUM ACRYLOYL-DIMETHYLTAURATE/VP COPOLYMER, FRAGRANCE, SQUALANE, METHYLPARABEN, XANTHAN GUM, DISODIUM EDTA, CERAMIDE 3, SODIUM HYALURONATE, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN.

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  • Warnings

    For external use only.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash or irritation develops and lasts.

    Do not use on open wounds.

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

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  • STORAGE AND HANDLING

    Store at room temperature.

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  • QUESTIONS

    For more information call 1-888-925-8989 or visit www.mederma.com

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  • SPL UNCLASSIFIED SECTION

    Manufactured for Merz Pharmaceuticals, Greensboro, NC 27410
    Made in Germany © 2007 Merz Pharmaceuticals

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  • PRINCIPAL DISPLAY PANEL - 20g Carton

    SPF 30
    sunscreen

    SKIN CARE FOR SCARS™
    MEDERMA®
    CREAM

    NET WT 0.70 OZ. (20g)

    MERZ®

    PRINCIPAL DISPLAY PANEL - 20g Carton
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  • INGREDIENTS AND APPEARANCE
    MEDERMA 
    avobenzone, octocrylene, and oxybenzone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0259-3192
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg  in 1 g
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 100 mg  in 1 g
    OXYBENZONE (OXYBENZONE) OXYBENZONE 60 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0259-3192-05 0.5 g in 1 PACKET
    2 NDC:0259-3192-20 1 in 1 CARTON
    2 20 g in 1 TUBE
    3 NDC:0259-3192-50 1 in 1 CARTON
    3 50 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part352 12/01/2007
    Labeler - Merz Pharmaceuticals, LLC (126209282)
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