Pain Cream
FDA Label NDC 79804-260

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eagle Labs Inc. for the product Pain Cream (NDC 79804-260). 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 active ingredient, purpose, uses:, when using this product, stop usage immediately and as a doctor if:, if pregnant or breast-feeding:, keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Menthol 6% Topical Analgesic

Camphor 5% Topical Analgesic

Purpose

Topical Analgesic

Uses:

For Temporary relief of aches and pains of muscles and joints associated with arthritis, bachaches, strains, or sprains. 

For Temporary relief of aches and pains of muscles and joints associated with arthritis, bachaches, strains, or sprains. 

For external use only. Do not use if safety seal is damaged or missing. 

When Using This Product

Use only as directed: Avoid contact with eyes or mucous membranes: Do not apply directly to wounds or damaged skin: Do no use in combination with other ointments, creams, or sprays: Wash hands with cool water after each use: Do not sue with a heat pad or device. 

Stop Usage Immediately And As A Doctor If:

Condition worsens or symptoms persist for more than 7 days. 

If Pregnant Or Breast-Feeding:

Ask a health professional before use

Keep Out Of Reach Of Children

If ingested, get medical help, or contact poison control center immediately: 1-800-222-1222

Directions:

Adults and children over 12 years old: Apply to affected area - do not apply more than 4 times adaily: Children 12 years or younger: Consult a doctor

Other Information

Flammable: Keep away from excessive heat or open flame. Keep out of direct sunlight: Store at 50-86F (15-30C)

Inactive Ingredients:

Bis-Vinyl Dimethicone/Dimthicone Copolymer, C13-C14 Isoparaffin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycol Stearate, Jojoba Oil, Laureth-7, Lavender Oil, Phenoxyethanol, Polyarylamide, Shea Butter, Simethicone, Sodium Acrylate/Sodium Acrylol Dimethyl Taurate Copolymer, Spearmint Oil, Water.

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