Country: United States
Language: English
Source: NLM (National Library of Medicine)
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)
Nature City, LLC
TOPICAL
OTC DRUG
Topical analgesic Temporarily relief of minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises Stop use and ask doctor if • condition worsens • if symptoms persists for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops.
OTC monograph not final
TRUE PAIN RELIEF PLUS- METHYL SALICYLATE, MENTHOL, CAPSAICIN LOTION NATURE CITY, LLC _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._ ---------- TRUE PAIN RELIEF PLUS _ACTIVE INGREDIENTS:_ Methyl Salicylate 10.00% w/w Menthol 1.25% w/w Capsaicin 0.025% w/w _PURPOSE_ Topical analgesic _USES:_ Temporarily relief of minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises _WARNINGS:_ FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT • use only as directed · do not bandage tightly or use with a heating pad • do not apply to wounds or damaged skin AVOID CONTACT WITH EYES AND MUCOUS MEMBRANES STOP USE AND ASK DOCTOR IF • condition worsens • if symptoms persists for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops. IF PREGNANT OR BREAST-FEEDING, ask a health care provider before use. KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, get medical help or contact a Poison Control Center right away. _DIRECTIONS:_ ADULTS AND CHILDREN OVER 12 YEARS • apply generousely to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 4 times daily • wash hands with soap and water after use CHILDREN 12 YEARS OR YOUNGER: consult a doctor. _INACTIVE INGREDIENTS:_ Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Camphor, Caprylyl Glycol, Cetyl Alcohol, Disodium EDTA, Isopropyl Myristate, Methylisothiazolinone, PEG-8, Triethanolamine, Water TRUE PAIN RELIEF PLUS methyl salicylate, menthol, capsaicin lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:69180-001 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH METHYL SALICYLATE (UN Read the complete document