Pain Relief Rub
FDA Label NDC 43493-0001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avaria Health & Beauty Corp for the product Pain Relief Rub (NDC 43493-0001). 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, indications & usage, warnings, dosage & administration, inactive ingredient, otc - purpose, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Camphor 4%, Menthol 4%, Methyl Salicylate 11%

Indications & Usage

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, back ache, strains, bruises, and sprains.

Warnings

Warnings

For external use only. Use only as directed.  Consult your doctor before use if you have allergies to aspirin or salicylate.  Avoid contact with eyes and mucous membranes.  If contact occurs, flush with water for 15 minutes.  Do not apply to wounds or damaged skin.  If pain persists for more than 7 days or becomes worse consult a physician.  Children under 12 years of age should consult a physician before use. 

Dosage & Administration

Directions

Adults and children 12 years of age and older:  use no more than 3 to 4 times daily.  Apply cream to affected  areas and thoroughly massage until penetrated.  Wash hands with soap and water after use.

Otc - Purpose

Purpose

Topical Analgesic.


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.

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