Otc - Active Ingredient
Active Ingredients:
Menthol 5%
Inspiration Academy Menthol Cooling Pain Cream
FDA Label NDC 76348-900
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 Inspiration Academy Menthol Cooling Pain Cream (NDC 76348-900). 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 otc - active ingredient, otc - keep out of reach of children, otc - purpose, otc - questions, otc - stop use, otc - when using, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Purpose
Purpose
Topical Analgesic
Otc - Questions
Questions or Comments
PHONE: (941) 795-5466 (LION)
Otc - Stop Use
Stop use and ask a doctor if
condition worsens or if symptoms persist for more than seven days or clear up and occur again within a few days
Otc - When Using
When using this product:
- Do not bandage tightly
- avoid contact with eye
- do not apply to wounds or damaged skin
- do not use heating pads or other heating devices.
Dosage & Administration
Directions:
adults and children 12 years of age and older
- apply generously to affected area
- massage into painful area until thoroughly absorbed into skin
- repeat as necessary
Inactive Ingredient
Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter,
Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water,
Emulsifying Wax, Fragrance, Hamamelis Virginiana (Witch Hazel), Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oil,
Laureth-7, Lobelia Inflata (Lobelia) Flower Extract, Magnesium Chloride, Magnesium Gluconate, Magnesium Myristate, Magnesium Orotate, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Leaf Oil, Olea europaea (Olive) Oil,
Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Xanthan Gum.
Indications & Usage
Uses:
for temporary relief of minor aches and pains associated with sore muscles, joint discomfort, strains, sprains, bruises and arthritis.
Warnings
For external use only
Recent Major Changes
Dosage and Administration
The only change is the effective date
Indications and Usage
The only change is the effective date
Package Label.Principal Display Panel
PACKAGE LABEL AND BOX ART
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