Pain Relieving 4 g/100g
menthol · GEL · Safetec of America, Inc.
Pain Relieving is a gel containing menthol at 4 g/100g, taken topical. Manufactured by Safetec of America, Inc..
Key Facts
- Brand Name
- Pain Relieving
- Generic Name
- menthol
- NDC Code (Product)
61010-4403- Manufacturer
- Safetec of America, Inc.
- Strength
- 4 g/100g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- M017
- Marketing Start
- 11/01/2019
Recall History
Ecometics, Inc.
CGMP DEVIATIONS
Ideaz Llc
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Parker Laboratories, Inc.
CGMP Deviations
Aruba Aloe Balm N.V.
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Unexo Life Sciences Private Limited
cGMP Deviations
Dr. Reddy's Laboratories, Inc.
Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
US Pharmaceuticals Inc.
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
US Pharmaceuticals Inc.
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Pharma-Natural Inc.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Wisconsin Pharmacal Company
Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains
Dosage & Administration
Directions Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.
Warnings
Warnings For external use only Do not use on wounds or damaged skin When using this product avoid contact with the eyes do not bandage tightly Stop use and ask doctor if symptoms persist for more than 7 days or clear up and occur again within a few days condition worsens irritation occurs If pregnant or breastfeeding, 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.
Frequently Asked Questions
What is Pain Relieving used for?
Pain Relieving contains menthol. It is a gel taken topical. Consult your doctor for specific uses.
Is Pain Relieving a controlled substance?
Pain Relieving is not classified as a controlled substance by the DEA.
What is the generic name for Pain Relieving?
The generic name for Pain Relieving is menthol. There are 12 other brand versions of menthol.
What is the NDC code for Pain Relieving 4 g/100g?
The NDC (National Drug Code) for Pain Relieving 4 g/100g is 61010-4403, listed by Safetec of America, Inc..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)