Mederma For Kids Gel
FDA Label NDC 73302-202

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 For Kids (NDC 73302-202). 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 - purpose, indications & usage, warnings, otc - when using, otc - ask doctor, otc - do not use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

ACTIVE INGREDIENTSPURPOSE
Allantoin 1%Skin Protectant

Indications & Usage

USES • Temporarily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS • For external use only

Otc - When Using

When using this product  • Do not get into eyes

Otc - Ask Doctor

Stop use and ask a doctor • Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days

Otc - Do Not Use

Do not use on • Deep or punctured wounds • Animal bites • Serious burns

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.

Dosage & Administration

DIRECTIONS • Apply as needed

Storage And Handling

OTHER INFORMATION • Store at room temperature

Inactive Ingredient

INACTIVE INGREDIENTS • Water, PEG-4, Xanthan Gum, Alcohol, Allium Cepa (Onion) Bulb Extract, Fragrance, Methylparaben, Sorbic Acid, Ext. Violet 2, Red 4, Sodium Chloride, Sodium Sulfate

Otc - Questions

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

Principal Display Panel

MEDERMA® for Kids™

Clinically shown to visibly reduce the appearance of scars

For Ages 2+

Unique Triple-Action Formula with kid-friendly scent

No 1 Pediatrician recommended scar brand*

Skin Protectant

1 x Gel Tube

NET WT. 0.7 0z (20g)

Effective treatment, with Cepalin® botanical extract for old and new scars caused by:

  • Cuts & Scrapes
  • Stitches
  • Burns
  • Surgery

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

    • Collagen production
    • Cell renewal
    • Lock-in moisture

      • For best results: Start to use Mederma® for Kids™ as soon as their wound has closed and apply evenly at least 3 times a day for:

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

        • *No. 1 recommended brand of scar reduction treatments

        Mederma® for Kids™ is for use on children 2-12 years of age. Ask your doctor before use on children under the age of 2.

        Guaranteed results or your money back

        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.

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* Please review the disclaimer below.