The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Extra Strength Pain Relief (NDC 59779-620). 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.
Otc - Active Ingredient
Active ingredient PurposeMenthol 7.6%...................................................Topical AnalgesicMethyl Salicylate 29%.......................................Topical Analgesic
Otc - Purpose
Uses temporary relieves minor pain associated with: - arthritis - simple backache - muscle strains- muscle sprains - bruises - cramps
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
Uses temporary relieves minor pain associated with:
- arthritis - simple backache - muscle strains
- muscle sprains - bruises - cramps
Warnings
Warnings For external use onlyAllergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.When using this product - use only as directed - avoid contact with the eyes or mucous membranes- do not bandage tightly or use with a heating pad - do not apply to wounds or damaged skinAsk a doctor before use if - condition worsens - redness is present - irritation develops - symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast-feeding, ask a health professional before use.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 generously to affected area- massage into painful area until thoroughly absorbed into skin- repeat as necessary, but no more than 4 times dilychildren under 12 years of age: consult a doctor
Inactive Ingredient
Inactive Ingredients parrafin, petrolatum
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