Mederma Scar Cream
FDA Label NDC 0113-4083

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by L. Perrigo Company for the product Mederma Scar Cream (NDC 0113-4083). 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 active ingredients, purpose, uses, warnings, do not use on, keep out of reach of children., when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 3%

Octocrylene 10%

Oxybenzone 6%

Purpose

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, 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.

Questions Or Comments?

  • For more information call 1-833-426-6733 or visit www.mederma.com

Package Label.Principal Display Panel

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

MEDERMA®

Scar Cream + SPF 30

Sunscreen

Triple-Action Formula to help

• Protect from harmful UVA/B exposure

• Retain moisture

• Production of collagen

#1 DOCTOR & PHARMACIST recommended scar brand

CREAM TUBE

NET WT. 0.7 Oz (20g)

PERRIGO SelfCareTM

Mederma (Carton)

Mederma (Carton)

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