Label: THERACARE PAIN RELIEVING MUSCLE VANISHING SCENT- menthol, unspecified form gel
- NDC Code(s): 71101-218-01
- Packager: Veridian Healthcare
- 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 February 24, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only.
Do not use
- on wounds or damaged skin
- with a heating pad
- on a child under 12 years of age with arthritis-like conditions
When using this product
- use only as directed
- avoid contact with eyes or mucous membranes
- do not bandage tightly
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 57 g Tube Carton
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INGREDIENTS AND APPEARANCE
THERACARE PAIN RELIEVING MUSCLE VANISHING SCENT
menthol, unspecified form gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71101-218 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 25 mg in 1 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EDETATE DISODIUM (UNII: 7FLD91C86K) BENZYL ALCOHOL (UNII: LKG8494WBH) CAMPHOR (NATURAL) (UNII: N20HL7Q941) CARBOMER 940 (UNII: 4Q93RCW27E) DMDM HYDANTOIN (UNII: BYR0546TOW) ISOCETETH-20 (UNII: O020065R7Z) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71101-218-01 1 in 1 CARTON 11/01/2021 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 11/01/2021 Labeler - Veridian Healthcare (830437997) Establishment Name Address ID/FEI Business Operations ANICARE PHARMACEUTICALS PRIVATE LIMITED 916837425 manufacture(71101-218)