FDA Label for Extra Strength Pain Relief Cream
View Indications, Usage & Precautions
Extra Strength Pain Relief Cream Product Label
The following document was submitted to the FDA by the labeler of this product Sagely Enterprises Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Menthol 10%
Purpose
Menthol 10%..............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 wtihin 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
Extra Strength Pain Relief Cream
Instant Cooling
With 10% Menthol
95% Natural Ingredients
4 FL OZ / 118 ML
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