Otc - Active Ingredient
Menthol 5 percent
Op6 Menthol Cooling Pain Cream
FDA Label NDC 76348-680
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 Op6 Menthol Cooling Pain Cream (NDC 76348-680). 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, warnings, otc - keep out of reach of children, otc - purpose, dosage & administration, inactive ingredient, uses, recent major changes, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
For external use only
When using this product do not bandage tightly
avoid contact with eye
do not apply to wounds or damaged skin
Stop use and ask doctor
if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep out of reach of children
If swallowed get medical help or contact Poison Control Center right away
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
Topical Analgesic
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
Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa (Hempseed) Oil and Hemp Derived Cannabidiol (CBD) Extract and proprietary terpene blend (Myrcene, b-Caryophyllene, d-Limonene, Humulene, Terpinolene, a-Pinene, Linalool, b-Pinene, Valencene, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Deionized Water, Emulsifying Wax, Glyceryl Stearate, Grapefruit Oil, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Olus (Vegetable) Oil, PEG-100, Phenoxyethanol, Polyacrylamide, Stearic Acid
Uses
for temporary relief of minor aches and pains asssociated with
arthritis
simple backache
muscle strains
sprains
bruises
Recent Major Changes
SIMPLE DATE CHANGE
Nothing considered as major
Questions Or Comments
631 697 0296
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