Pain Relieving Gel
FDA Label NDC 61010-4403

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Pain Relieving (NDC 61010-4403). 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 other, active ingredient, purpose, use, warnings, otc - ask doctor, when using this product:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Menthol USP 4%

Purpose

Cooling Pain Relief

Use

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backache, strains sprains.

Warnings

  • For external use only.

    • Flammable: Keep away from excessive heat or open flame.

Otc - Ask Doctor

Ask a doctor before use if you have: sensitive skin.

When Using This Product:

  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device

Stop Use And Ask A Doctor If:

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding: Ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help, contact a physician or Poison Control Center right away

Directions

  • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
  • Children under 2 years of age: Consult a physician

Other Information

Store in a cool dry place.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Brilliant Blue, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract (Green Tea Leal), Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Purified Water, Silicon Dioxide, Tartrazine, TocopheryI Acetate, Triethanolamine.

Package Label.Principal Display Panel

Principal Display Panel – 4 oz Pain Relieving Gel

Safetec®

Pain Relieving Gel

For Minor Aches & Pains of Muscles & Joints

Net Wt. 4 oz. (113.4g)

Reorder No. 58002

Manufactured for: Safetec of America, Inc.

Buffalo, NY 14215 I 1-800-456-7077

Made in India KD/739

Principal Display Panel – 4 Oz Pain Relieving Gel (Pai05 0000 01)

Principal Display Panel – 4 Oz Pain Relieving Gel (Pai05 0000 01)

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