Label: ARTHRITIS HOT- menthol and methyl salicylate cream
- NDC Code(s): 41167-0600-3
- Packager: Chattem, 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.
Drug Label Information
Updated December 1, 1998
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
For external use only
Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
When using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- avoid contact with eyes or mucous membranes
- do not apply to wounds or damaged, broken or irritated skin
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
- irritation develops
- use only as directed
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
menthol and methyl salicylate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ESTERS WAX (UNII: D072FFP9GU) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0600-3 1 in 1 CARTON 12/01/1998 1 85 g in 1 TUBE; 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 12/01/1998 Labeler - Chattem, Inc. (003336013)