Active Ingredients
Menthol 2%
Methyl Salicylate 10%
Pain Therapy
FDA Label NDC 76348-640
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Inc. for the product Pain Therapy (NDC 76348-640). 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, when using this product, stop use and ask doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Topical Analgesic
Uses
Temporarily relieves minor aches and pains of muscle and joints due to: arthritis, simple backache, sprains, strains and bruises
Warnings
For external use only
When Using This Product
- Do not apply to wounds or damaged skin
- Do not bandage tightly
- Do not use in or near eyes; if product gets into eyes rinse thoroughly with water
- Do not use with an electric heating pad
Stop Use And Ask Doctor If
- Conditions worsen
- Symptoms last for more than 7 days or clear up and occur again within a few days
- A rash or irritation develops
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.
Inactive Ingredients
Allantoin, Benzoic Acid, C13-14 Isoparaffin, Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Dehydroacetic Acid, Deionized Water, Emu Oil, Eucalyptus Globulus Leaf Oil, Glyceryl Stearate, Laureth-7, Mentha Piperita (Peppermint) Oil, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Stearic Acid.
Arctic Heat
Dual Active Botanical Warming Formula with Emu Oil
Otc - Questions
Manufactured by:
Renu Labs Inc.
Ivyland, PA 18974
www.RenuLabs.com
Dosage & Administration
Directions
Adults and children 12 years of age and
older: Apply directly to affected area no more than 3 to 4 times daily.
Recent Major Changes
No major changes to any section.
This is a simple product name change.
Package Label.Principal Display Panel
RANCHO SAN DIEGO PAIN RELIEF TUBE
Rancho Pr Tube (Tube)
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