First Aid Research Chafe Away Medicated Healing
FDA Label NDC 75983-738

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by First Aid Research Corp. for the product First Aid Research Chafe Away Medicated Healing (NDC 75983-738). 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, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, storage and handling, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredients                                                                    Purpose

Menthol 0.44% .......................................................................External analgesic, first aid antiseptic

Zinc Oxide 20% .....................................................................Skin protectant/moisture barrier

Otc - Purpose

Uses

  • A moisture barrier that helps prevent and relieve chafed, chapped or cracked skin
  • Helps protects from drying effects of wind and cold weather
  • Temporarily provides a soothing and protective coating over inflamed and painful tissue

Warnings

Warning

For external use only

Not for deep or puncture wounds, avoid contact with eyes

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

In case of accidental ingestion contact a physician or Poison Control Center immediately.

Indications & Usage

Directions

  • cleanse skin gently with mild skin cleanser
  • pat dry or allow to air dry
  • apply a thin layer of ointment to redened or irritated skin 2-4 times per day

Storage And Handling

Other information

  • Store at 20o to 25oC (68o to 77oF)
  • Lot No. and Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

Aloe Vera Gel, Butylated Hydroxytoluene, Calamine, Ergocalciferol, Liquid Paraffin, Methylparaben, Purified Lanolin, Purified Water, Retinol Palmitate, Tocopherol Acetate, Trolamine, White Petrolatum

Dosage & Administration

Distributed by:

First Aid Research Corp.

3375 Park Ave. Suite 2003

Wantagh, NY 11793 USA

www.firstaidresearch.com

Made in Korea

Package Label.Principal Display Panel

Image Of Carton Label (Farchafeaway)

Image Of Carton Label (Farchafeaway)

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