Active Ingredient
Capsacin; Analgesic
Menthol: Analgesic
Camphor: Analgesic
Pain Away
FDA Label NDC 79804-265
10 label sections · Submitted to the FDA by Eagle Labs Inc. · 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 Away (NDC 79804-265). 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, pain relief - topical analgesic, indications, warnings, when using this product, keep out of children, if pregnant or breastfeeding, flammable, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Pain Relief - Topical Analgesic
Analgesic
Indications
For the temporary relief of minor aches and pains of muscles and joints associated with
Simple backache
Arthritis
Strains
Bruises
Sprains
Warnings
- For extrernal use only
- Avoid Contact with the eyes
- Do not apply to wounds or bandaged skin
- Do not bandage tightly
- Condition worsens
- Symptoms persist for more than 7 days or cleear up and reoccur
- Redness is present
- irritation develops
Stop use and consult a doctor if:
When Using This Product
- Use only as directed
- Do not apply heat (heating pads) or apply patches to area
Keep Out Of Children
If accidentally swallowed get medical help or contact a poison control center immediately
If Pregnant Or Breastfeeding
If pregnant or breastfeeding, ask a health professional before use.
Keep out of the reach o children
If accidentally swallowed get medical help or contact a poison control center immediately
Flammable
Keep away from excessive heat or open flame
Keep away from excessive heat or open flame
Inactive Ingredients
Isopropanol, MCT, Phenoxyethanol, Simethicone
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 consult a doctor.
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