Analgesic Spray
FDA Label NDC 61010-8200

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 Analgesic (NDC 61010-8200). 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 ingredients, purpose, uses:, warnings:, otc - keep out of reach of children, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Other

Pain Spray

Drug Facts

Active Ingredients

USP Menthol 7%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints.

Warnings:

  • For external use only
  • Flammable. Keep away from flame.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children- if swallowed get medical help or contact a poison center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly. Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Directions:

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Other Information:

Store at room temperature.

Inactive Ingredients:

Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil.

Manufactured by
SAFETEC OF AMERICA, Inc. Buffalo, NY 14215
800-456-7077 www.safetec.com

Principal Display Panel

NDC 61010-8200-1

Safetec

First Aid

Pain Spray

For Temporary

Pain Relief of

Minor Aches

And Pains

4 fl. oz. (118 ml)

Principal Display Panel (Saf0h 0000 01)

Principal Display Panel (Saf0h 0000 01)

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