Country: United States
Language: English
Source: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
RENU LABORATORIES, INC.
TOPICAL
OTC DRUG
Purpose Topical Analgesic Uses for temporary relief of minor aches and pains of muscles and joints associated with - bruises - sprains - arthritis - strains Stop use and ask a doctor if - Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
OTC monograph not final
OP 6 MENTHOL COOLING ROLL ON- MENTHOL LIQUID RENU LABORATORIES, INC. _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- OP 6 MENTHOL COOLING ROLL ON _ACTIVE INGREDIENT_ Menthol 5 percent _PURPOSE_ Topical Analgesic _USES_ for temporary relief of minor aches and pains of muscles and joints associated with bruises sprains arthritis strains _WARNINGS_ FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT Do not bandage tightly avoid contact with eyes do not apply to wounds or damaged skin do not use with heating pads or other heating devices. STOP USE AND ASK A 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 a Poison Control Center right away. _DIRECTIONS_ adults and children 12 years of age and older, apply to affected area no more than 10 times a day as needed for pain. children under 12 years of age: do not use, consulta a doctor. Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Deionized Water, Fragrance, Hamamelis Virginiana (Witch Hazel), Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate. QUESTIONS? COMMENTS? www.HempforLifeWellness.com PRODUCT LABEL AND PRODUCT BOX OP 6 MENTHOL COOLING ROLL ON menthol liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:76348-670 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.2 g in 84 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH LINALOOL, (+/-)- (UNII: D81QY6I88E) POLYSOR Read the complete document