Mederma Scar Cream by HRA Pharma America, Inc. / Merz Pharma GmbH & Co KGaA Drug Facts

Mederma Scar Cream by

Drug Labeling and Warnings

Mederma Scar Cream by is a Otc medication manufactured, distributed, or labeled by HRA Pharma America, Inc., Merz Pharma GmbH & Co KGaA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDERMA SCAR CREAM- avobenzone, octocrylene, and oxybenzone cream 
HRA Pharma America, Inc.

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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Drug Facts

ACTIVE INGREDIENTSPURPOSE
Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%Sunscreen

USES Helps prevent sunburn

WARNINGS  Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only

Do not use on Damaged or broken skin

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

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

Stop use and ask a doctor If rash occurs

DIRECTIONS For sunscreen use: Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Children under 6 months: Ask a doctor Use a water-resistant sunscreen if swimming or sweating

OTHER INFORMATION Store at room temperature Protect this product from excessive heat and direct sun

INACTIVE INGREDIENTS Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Panthenol, Glycerin, Pentylene Glycol, Butyrospermum Parkii (Shea) Butter, Phenoxyethanol, Allium Cepa (Onion) Bulb Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Fragrance, Squalane, Methylparaben, Xanthan Gum, Disodium EDTA, Sodium Hyaluronate, Butylparaben, Ethylparaben,  Isobutylparaben, Propylparaben, Ceramide NP, Tocopherol

QUESTIONS OR COMMENTS? For more information call 1-833-426-6733 or visit www.mederma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEDERMA®

Scar Cream + SPF 30  

Clinically shown to visibly reduce the appearance of scars while protecting from sun damage

Unique Triple-Action Formula penetrates into the skin

No 1 Doctor & Pharmacist recommended scar brand*

Sunscreen

1 x CREAM TUBE

NET WT. 0.7 0z (20g)

MEDERMA® Scar Cream + SPF 30 is an effective treatment, with Cepalin® botanical extract for old and new scars caused by:

  • Acne
  • Surgery
  • Burns
  • Injury

Unique Triple-Action Formula penetrates beneath the surface of the skin to help:

  • Protect from harmful UVA/B exposure
  • Retain moisture
  • Production of collagen

Used daily: Mederma® Scar Cream + SPF 30 is clinically shown to improve the softness, texture and appearance of scars and protect from harmful UVA/UVB exposure.

For best results: Start to use Mederma® Scar Cream + SPF 30 as soon as your wound has closed and apply evenly at least 3 times daily for:

  • 8 weeks on new scars
  • 3-6 months on old scars

Guaranteed results or your money back

*No. 1 recommended brand of scar reduction treatments

Manufactured for Laboratoire HRA Pharma
Distributed by: HRA Pharma America, Inc.
Morristown, NJ 07960.
Made in Germany.
Mederma® is a registered trademark of HRA Pharma

Lot

Exp. Date

carton
MEDERMA SCAR CREAM 
avobenzone, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73302-200
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
Water (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
ALCOHOL (UNII: 3K9958V90M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
PANTHENOL (UNII: WV9CM0O67Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ONION (UNII: 492225Q21H)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
SQUALANE (UNII: GW89575KF9)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CERAMIDE NP (UNII: 4370DF050B)  
Tocopherol (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73302-200-201 in 1 CARTON10/01/202011/30/2023
120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35210/01/202011/30/2023
Labeler - HRA Pharma America, Inc. (081160441)
Establishment
NameAddressID/FEIBusiness Operations
Merz Pharma GmbH & Co KGaA342543179manufacture(73302-200)

Revised: 10/2022