Active Ingredient
Menthol 5%
Pain Relief Cream
FDA Label NDC 82075-410
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sagely Enterprises Inc. for the product Pain Relief Cream (NDC 82075-410). 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, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Menthol 5%.................Topical analgesic
Uses
temporarily relieves the minor aches and pains of muscles and joints associated with:
- strains
- bruises
- simple backache
- arthritis
- sprains
Warnings
For external use only.
Otc - Do Not Use
Do not use
- on wounds or damaged, broken, or irritated skin
- with a heating pad
Otc - When Using
When using this product
- avoid contact with eyes or mucous membranes
- do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
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.
Directions
- Use only as directed
- 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: ask a doctor
Inactive Ingredients
Water, Propanediol, Cetyl Alcohol, Caprylic/Capric Triglyceride, Stearyl Alcohol, Glycerin, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Glucoside, Cetearyl Alcohol, Diheptyl Succinate, Xanthan Gum, Boswellia Serrata Resin Extract, Safflower (Carthamus Tinctorius) Seed Oil, Hemp (Cannabis Sativa) Seed Oil, Marula (Sclerocarya Birrea) Seed Oil, Argan (Argania Spinosa) Kernel Oil, Tocopheryl Acetate, Camphor, Peppermint (Mentha Piperita) Oil, Glyceryl Caprylate, Caprylhydroxamic Acid, Sodium Hydroxide
Package Label.Principal Display Panel
Sagely Naturals
Pain Relief Cream
Instant Cooling
With 5% Menthol
95% Natural Ingredients
4 FL OZ / 118 ML
1 (0001)
2 (0002)
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