Rite Aid Ultra Strength Muscle Rub
FDA Label NDC 11822-0406

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Rite Aid Ultra Strength Muscle Rub (NDC 11822-0406). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                 PurposeCamphor 4%......................................................External AnalgesicMenthol 10%......................................................External AnalgesicMethyl Salicylate 30%.........................................External Analgesic

Otc - Purpose

UsesFor the temporary relief of minor aches and pains of muscles and joints associated with:- simple backache - arthritis - strains - bruises - sprains

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.

Indications & Usage

UsesFor the temporary relief of minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - bruises - sprains

Warnings

Warnings For external use only- avoid contact with eyes and mucous membranes- do not bandage tightly- do not use with a heating pad- do not apply to wounds or damaged skinStop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or symptoms clear up and occur again. Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions - Adults and children 12 years of age and older - apply to affected area not more than 3 to 4 times daily- Children under 12 years of age do not use, ask a doctor.Other information store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

Inactive Ingredient

Inactive Ingredientspurified water, stearic acid, glyceryl stearate, PEG-100 stearate, lanolin, triethanolamine, polysorbate 80, carbomer, disodium EDTA, potassium hydroxide

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