Otc - Active Ingredient
| ACTIVE INGREDIENTS | PURPOSE |
| Avobenzone 3%, Octocrylene 10%, Oxybenzone 6% | Sunscreen |
Mederma Scar Cream
FDA Label NDC 73302-205
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hra Pharma America, Inc. for the product Mederma Scar Cream (NDC 73302-205). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, otc - when using, otc - stop use, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
USES • Helps prevent sunburn
Warnings
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
Otc - Do Not Use
Do not use on • Damaged or broken skin
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - When Using
When using this product • Keep out of eyes • Rinse with water to remove
Otc - Stop Use
Stop use and ask a doctor • If rash occurs
Dosage & Administration
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
Storage And Handling
OTHER INFORMATION • Store at room temperature • Protect this product from excessive heat and direct sun
Inactive Ingredient
INACTIVE INGREDIENTS • Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Panthenol, Glycerin, Pentylene Glycol, Phenoxyethanol, Butyrospermum Parkii (Shea) Butter, Allium Cepa (Onion) Bulb Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Fragrance, Squalane, Methylparaben, Xanthan Gum, Propylparaben, Disodium EDTA, Sodium Hyaluronate, Ethylparaben, Ceramide NP, Tocopherol.
Otc - Questions
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
No. 1 Doctor & Pharmacist recommended scar brand*
Sunscreen
1 x CREAM TUBE
NET WT. 0.7 0z (20g)
Unique Triple-Action Formula penetrates into the skin
MEDERMA® Scar Cream + SPF 30 is an effective treatment, with Cepalin® botanical extract for old and new scars caused by:
- Acne
- Surgery
- Burns
- Injury
- Protect from harmful UVA/B exposure
- Retain moisture
- Production of collagen
- 8 weeks on new scars
- 3-6 months on old scars
Unique Triple-Action Formula penetrates beneath the surface of the skin to help:
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:
*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
Guaranteed results or your money back
Lot
Exp. Date
Carton (Carton)
* Please review the disclaimer below.
