Label: FORMULA45 ARTHRITIS BLEND- methyl salicylate, menthol, unspecified form cream
- NDC Code(s): 70169-701-01
- Packager: Shift Consulting Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated February 7, 2017
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- Drug Facts:
- Active Ingredient:
Methyl Salicylate 20.00%
For the temporarily relief of minor aches and pains of the muscles and joints associated with
- simple backache
- and sprains
For external use only
Allergy Alert: If you had prior allergic reaction to aspirin or salicylate, please consult a physician before use.
Do not use
- on wounds or damaged skin
- with a heating pad
- children 12 years of age with arthritic conditions
Stop use and ask a physician if
- condition worsens or symptoms persist for more than 7 days
- symptoms clearup and occur again within a few days
- excessive skin irritation occurs.
Keep out of reach of children.
In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Use only as directed
- Adults and children over 12 years of age apply to affected area not more than 3 to 4 times daily
- children under 12 years of age consult a physician.
- Other Ingredients:
Aqua (deionized water), arnica montana (arnica) extract, blue 1, boswellia serrata extract, C13-14 isoparaffin, cetyl alcohol, chondroitin sulfate, dimethyl sulfone (MSM), ethylhexylglycerin, glucosamine sulfate, glycerin, glyceryl stearate, laureth-7, PEG-100 stearate, phenoxyethanol, polyacrylamide, polysorbate-20, stearic acid, yellow 5.Close
- Package Labeling:
- INGREDIENTS AND APPEARANCE
FORMULA45 ARTHRITIS BLEND
methyl salicylate, menthol, unspecified form cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70169-701 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 200 mg in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 100 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ARNICA MONTANA (UNII: O80TY208ZW) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LAURETH-7 (UNII: Z95S6G8201) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) STEARIC ACID (UNII: 4ELV7Z65AP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70169-701-01 1 in 1 CARTON 02/07/2017 1 113 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/16/2015 Labeler - Shift Consulting Group, Inc. (079991681)