Ultra Strength Pain Relief
FDA Label NDC 41520-317

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Car One for the product Ultra Strength Pain Relief (NDC 41520-317). 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 ingredients                             purpose, uses, warnings, flammable, when using this product, stop use and ask a doctor if, keep out of reach of the children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients                             Purpose

Camphor – 4.00%                                Topical Analgesic
Menthol – 10.00%                               Topical Analgesic
Methyl Salicylate – 30.00%                Topical Analgesic

Uses

  • temporarily relieves minor pain associated with:
  • arthritis
  • simple backache
  • muscle strains
  • bruises
  • muscle sprains

Warnings

​For external use only

Flammable

 • keep away from fire or flame. • avoid long term
storage above 104˚F. • do not puncture or incinerate. Contents under
pressure. • do not store at temperatures above 120˚F

• do not use while smoking or near heat or flame
• avoid long term storage above 104F
• do not puncture or incinerate. Contents under pressure
• do not store at temperature above 120F

When Using This Product

• avoid contact with eyes and mucous membranes
• do not apply to wounds or damages skin
• do not bandage tightly or use with a heating pad
• use only as directed

Stop Use And Ask A Doctor If

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of The Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• shake well
• adults and children 2 years of age and older: spray on affected area, not more than 3 to 4 times daily
• children under 2 years of age: consult a doctor

Inactive Ingredients

Alcohol Denat.

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