Label: MENTHOLATUM DEEP HEATING RUB EXTRA STRENGTH- menthol and methyl salicylate cream
- NDC Code(s): 10742-2002-4, 10742-2002-5
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients
Methyl salicylate 30%Close
Menthol - External analgesic
Methyl salicylate - External analgesicClose
temporarily relieves minor aches and pains of muscles and joints due to
- simple backache
For external use only
When using this product
- use only as directed
- do not get into eyes or on mucous membranes
- do not apply to wounds or damaged skin
- do not bandage tightly
- do not use with heating pad or apply external heat
Stop use and ask a doctor if
- condition worsens
- excessive irritation of the skin develops
- pain persists for more than 7 days
- symptoms clear up and occur again within a few days
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
- children under 2 years: ask a doctor
- Inactive ingredients
glyceryl stearate, isoceteh-20, poloxamer 407, purified water, quaternium-15, sodium lauryl sulfate, sorbitan stearateClose
- Questions or comments?
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- INGREDIENTS AND APPEARANCE
MENTHOLATUM DEEP HEATING RUB EXTRA STRENGTH
menthol, methyl salicylate cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10742-2002 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 80 mg in 1 g METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 300 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE POLOXAMER 407 WATER QUATERNIUM-15 SODIUM LAURYL SULFATE SORBITAN MONOSTEARATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-2002-4 2 in 1 CARTON 1 57 g in 1 TUBE 2 NDC:10742-2002-5 57 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/15/1992 Labeler - The Mentholatum Company (002105757)