Label: MENTHOLATUM DEEP HEATING RUB EXTRA STRENGTH- menthol, methyl salicylate cream
- NDC Code(s): 10742-2002-4
- Packager: The Mentholatum Company
- 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 November 8, 2017
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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, other heat sources, or right after a shower/bath
- do not use in combination with other external analgesic products
Stop use and ask a doctor if
- condition worsens
- excessive irritation, burning, or discomfort of the skin develops
- symptoms persist for more than 7 days or clear up and occur again within a few days
If pregnant or breast-feeding, ask a healthcare professional before use.
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, sodium lauryl sulfate, sorbitan stearateClose
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- Package/Label Principal Display Panel
- INGREDIENTS AND APPEARANCE
MENTHOLATUM DEEP HEATING RUB EXTRA STRENGTH
menthol, methyl salicylate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-2002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 80 mg in 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 300 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLOXAMER 407 (UNII: TUF2IVW3M2) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-2002-4 2 in 1 CARTON 12/15/1992 1 57 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 12/15/1992 Labeler - The Mentholatum Company (002105757)