Skin Shield
FDA Label NDC 63736-293

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals for the product Skin Shield (NDC 63736-293). 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, uses, warnings, other, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Purpose

Active ingredientsPurpose
Benzethonium chloride 0.2%First aid antiseptic
Dyclonine hydrochloride 0.75%Topical analgesic

Uses

first aid for the temporary relief of pain and to help protect against infection in minor cuts, scrapes and burns.

Warnings

For external use only

Other

Flammable: Keep away from fire or flame

Distributed by: Insight Pharmaceuticals Corp.
Langhorne, PA 19047-1749

Otc - Do Not Use

Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor. Do not use for longer than 1 week unless directed by a doctor.

Otc - When Using

When using this product avoid contact with the eyes.

Otc - Stop Use

Stop use and ask a doctor if the condition gets worse, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

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.

Directions

Adults and children 2 years of age and older:

  • Clean the affected area.
  • Dry thoroughly.
  • Brush a small amount of product on the area 1 to 3 times daily and let dry.
  • Hold knees, elbows, knuckles in bent position during application and drying.
  • For more protection, apply second coat.
  • Children under 2 years of age:

    • Consult a doctor.

Other Information

  • To remove: peel off or apply a fresh layer of product over dry product and using gauze, rub off gently while still wet.
  • Cap bottle tightly
  • Store at room temperature 15°-25°C (59°-77°F).
  • Keep carton for full drug facts.

Inactive Ingredients

acetone, amyl acetate, castor oil, drometrizole, ethyl acetate, nitrocellulose, SD alcohol 40-B

Questions?

call 1-800-344-7239

Principal Display Panel - 26.6 Ml Bottle Carton

ECONOMY SIZE

Skin Shield®
Liquid Bandage
First Aid Antiseptic
Pain Reliever

NET WT. 0.9 fl oz (26.6 ml)

Principal Display Panel (26.6 ml Bottle Carton)

Principal Display Panel (26.6 ml Bottle Carton)

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