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Mederma

Merz Pharmaceuticals, LLC

Mederma CREAM


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

Active Ingredients

AVOBENZONE 3%, OCTOCRYLENE 10%, OXYBENZONE 6%

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.

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.

Store at room temperature.

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

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

PRINCIPAL DISPLAY PANEL - 20g Carton

SPF 30
sunscreen

SKIN CARE FOR SCARS™
MEDERMA®
CREAM

NET WT 0.70 OZ. (20g)

MERZ®

Mederma

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 30 mg
OCTOCRYLENE Octocrylene 100 mg
OXYBENZONE OXYBENZONE 60 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0259-3192-05 0.5 in 1 PACKET
2 20 in 1 TUBE
3 50 in 1 TUBE
4 NDC:0259-3192-50 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2007-12-01


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