Label: MOUNTAIN ICE SPORTS PAIN RELIEF- menthol, camphor gel
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Contains inactivated NDC Code(s)
NDC Code(s): 72793-200-01, 72793-200-02, 72793-200-03, 72793-200-04 - Packager: Mountainside Medical Equipment, Inc.
- 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 June 24, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use:
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Warnings:
For external use only.
Flammable: keep away from excessive heat or open flame. Avoid contact with eyes or mucous membranes.
- Directions:
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Inactive Ingredients:
Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata (Frankincense) Oil, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Curcuma Longa (Turmeric) Root Oil, Dimethyl Sulfone, Dipotassium Glycyrrhizate, Ethylhexylglycerin, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Isopropyl Alcohol, L-Arginine, Limonene, Magnesium Sulfate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Spicata (Spearmint) Oil, Niacinamide, Panax Ginseng Root Extract, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Triethanolamine, Water (Aqua), Blue 1 (CI 42090)
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
MOUNTAIN ICE SPORTS PAIN RELIEF
menthol, camphor gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72793-200 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 6 g in 100 mL CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL 4 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) INDIAN FRANKINCENSE OIL (UNII: 5T1XCE6K8K) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) TURMERIC OIL (UNII: 6KGS8SP16U) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) ARGININE (UNII: 94ZLA3W45F) LIMONENE, (+)- (UNII: GFD7C86Q1W) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) TEA TREE OIL (UNII: VIF565UC2G) SPEARMINT OIL (UNII: C3M81465G5) NIACINAMIDE (UNII: 25X51I8RD4) ASIAN GINSENG (UNII: CUQ3A77YXI) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72793-200-01 6 mL in 1 PACKET; Type 0: Not a Combination Product 05/08/2020 2 NDC:72793-200-02 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/08/2020 06/14/2022 3 NDC:72793-200-03 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/08/2020 4 NDC:72793-200-04 99 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 05/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/08/2020 Labeler - Mountainside Medical Equipment, Inc. (119735871) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing, Inc. 793406000 MANUFACTURE(72793-200)
