Label: DR GOLDSONS- menthol, methyl salicylatw cream
- NDC Code(s): 72667-009-01
- Packager: Inspec Solutions LLC.
- 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 March 21, 2019
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- ACTIVE INGREDIENT
Methyl Salicylate 30%Close
Menthol 8% ...............................External Analgesic
Methyl Salicylate 30% ...............External AnalgesicClose
- INDICATIONS & USAGE
INDICATIONS & USAGE SECTION
Uses for temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.Close
For external use only
Do not use
- on wounds or damaged skin
- with heating padClose
- STOP USE
Stop use and ask a doctor if
- condition worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- excessive skin irritation occursClose
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.Close
- DOSAGE & ADMINISTRATION
- Use only as directed
- Adults and children over 12 years: Apply to affected area no more than 3 to 4 times daily.
- Children 12 years or younger: ask a doctor.
- Close cap tightly after use.Close
- INACTIVE INGREDIENT
Curcuma Longa (Turmeric) Root Extract
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
menthol, methyl salicylatw cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72667-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 8 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 30 g in 100 mL Inactive Ingredients Ingredient Name Strength POTASSIUM STEARATE (UNII: 17V812XK50) CURCUMA LONGA LEAF (UNII: H2HC4RY52C) CETYL PHOSPHATE (UNII: VT07D6X67O) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72667-009-01 113.4 mL in 1 JAR; Type 0: Not a Combination Product 04/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/21/2019 Labeler - Inspec Solutions LLC. (081030372) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC. 081030372 manufacture(72667-009)