Mederma® CREAM

Mederma® CREAM

Drug Labeling and Warnings

Drug Details

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MEDERMA- avobenzone, octocrylene, and oxybenzone cream 
Merz Pharmaceuticals, LLC

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.

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Mederma®
CREAM

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 - 20 g Tube Carton

SKIN CARE FOR SCARS
MEDERMA®
+SPF 30
SCAR
CREAM

NET WT. 0.70 OZ. (20g)
MERZ

PRINCIPAL DISPLAY PANEL - 20 g Tube Carton
MEDERMA 
avobenzone, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0259-3192
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ONION (UNII: 492225Q21H)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PANTHENOL (UNII: WV9CM0O67Z)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SHEA BUTTER (UNII: K49155WL9Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
SQUALANE (UNII: GW89575KF9)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CERAMIDE NP (UNII: 4370DF050B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0259-3192-050.5 g in 1 PACKET; Type 0: Not a Combination Product12/01/200702/15/2020
2NDC: 0259-3192-201 in 1 CARTON12/01/200702/15/2020
220 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 0259-3192-501 in 1 CARTON12/01/200702/15/2020
350 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/01/200702/15/2020
Labeler - Merz Pharmaceuticals, LLC (126209282)

Revised: 2/2020
 
Merz Pharmaceuticals, LLC


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