Label: COLD AND HEAT PAIN RELIEVING CREAM- menthol and methyl salicylate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72351-010-00 - Packager: SOTAC PHARMACEUTICALS PRIVATE LIMITED
- 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 August 9, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
SEE INSIDE LABEL FOR COMPLETE DRUG FACTS
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
- use only as directed
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD AND HEAT PAIN RELIEVING CREAM
menthol and methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72351-010 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 30 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ESTERS WAX (UNII: D072FFP9GU) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72351-010-00 208 g in 1 BOX; Type 0: Not a Combination Product 08/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/09/2018 Labeler - SOTAC PHARMACEUTICALS PRIVATE LIMITED (876894019)