Country: United States
Language: English
Source: NLM (National Library of Medicine)
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Painexx Corporation
TOPICAL
OTC DRUG
For the treatment of the minor aches and pains associated with arthritis Topical analgesic
OTC monograph not final
RINGMASTER RUBBING OIL- METHYL SALICYLATE LIQUID PAINEXX CORPORATION _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._ ---------- Rub every four hours as needed DIRECTIONS For external use only. Do not use if allergic to peanuts INACTIVE INGREDIENT Peanut Oil INDICATIONS AND USAGE For the treatment of the minor aches and pains associated with arthritis KEEP OUT REACH OF CHILDREN Keep out of reach of children PURPOS E Topical analgesic ACTIVE INGREDIENT Methyl Salicylate RINGMASTER RUBBING OIL methyl salicylate liquid Painexx Corporation PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:549 47-124 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 40 g in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH PEANUT O IL (UNII: 5TL50 QU0 W4) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:549 47-124- 31 30 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n Pro duc t 0 2/0 6 /19 50 2 NDC:549 47-124- 32 6 0 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n Pro duc t 0 2/0 6 /19 50 3 NDC:549 47-124- 33 120 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n Pro duc t 0 2/0 6 /19 50 4 NDC:549 47-124- 34 240 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n Pro duc t 0 2/0 6 /19 50 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph no t final pa rt348 0 2/0 6 /19 50 LABELER - Painexx Corporation (080069233) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Painexx Co rpo ratio n 0 8 0 0 6 9 233 ma nufa c ture (549 47-124) Revised: 2/2018 Read the complete document