Modere Sports Rub by Maple Mountain Group, Inc. Modere Sports Rub

Modere Sports Rub by

Drug Labeling and Warnings

Modere Sports Rub by is a Otc medication manufactured, distributed, or labeled by Maple Mountain Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MODERE SPORTS RUB- menthol 5% cream 
Maple Mountain Group, Inc.

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Modere Sports Rub

Active ingredient

Menthol 5%

Purpose

Menthol 5%..............Topical analgesic

Uses

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains

Warnings

For external use only

When using this product

• avoid contact with eyes or on mucous membranes
• do not apply to wounds or to damaged or very sensitive skin
• do not bandage tightly or use with a heating pad

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present or irritation develops

If pregnant or breast feeding,contact physician prior to use.

Keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control center right away.

Directions

• adults and children 12 years and over:Apply to affected area not more than three to four times daily
• children under 12 years:consult a physician

Inactive ingredients

Water, butylene glycol, isopentyldiol, stearic acid, cetyl alcohol, glycerin, polyglyceryl-3 methylglucose distearate, copaifera officinalis (balsam copaiba) resin oil, dimethyl sulfone, sodium acrylate/sodium acryloyldimethyl taurate copolymer, zea mays (corn) oil, c15-19 alkane, lysine aspartate, mentha piperita (peppermint) oil, cetyl hydroxyethylcellulose, potassium sorbate, stearyl glycyyrrhetinate, 1,2-hexanediol, caprylyl glycol, tetrasodium glutamate diacetate, polyglyceryl-6 laurate, salix alba (willow) bark extract, yeast polysaccharides, arnica montana flower extract, polyglycerin-6, panax ginseng root extract, panax quinquefolius root extract, capsicum frutescens fruit extract

MODERE

SPORTS RUB

menthol 5%

with skin-conditioning

white willow extract

125mL/4.2 FL OZ

MODERE SPORTS RUB 
menthol 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79400-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SALIX ALBA BARK (UNII: 205MXS71H7)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ASIAN GINSENG (UNII: CUQ3A77YXI)
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)
GLYCERIN (UNII: PDC6A3C0OX)
C15-19 ALKANE (UNII: CI87N1IM01)
AMERICAN GINSENG (UNII: 8W75VCV53Q)
TABASCO PEPPER (UNII: J1M3NA843L)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CORN OIL (UNII: 8470G57WFM)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)
PEPPERMINT OIL (UNII: AV092KU4JH)
LYSINE ASPARTATE (UNII: 23227F83U0)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
POLYGLYCERIN-6 (UNII: M51422LRAM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79400-101-01	125 mL in 1 TUBE; Type 0: Not a Combination Product	05/17/2021	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/17/2021	12/31/2023

Labeler - Maple Mountain Group, Inc. (161820212)

Establishment
Name	Address	ID/FEI	Business Operations
Maple Mountain Group, Inc.		161820212	label(79400-101)

Establishment
Name	Address	ID/FEI	Business Operations
Maple Mountain Group, Inc.		965790285	manufacture(79400-101)

Revised: 10/2023

Document Id: 08b6517d-c0e6-b4cf-e063-6394a90a6ab6

34390-5

Set id: c25233cd-4bda-1e1e-e053-2995a90af3bd

Version: 5

Effective Time: 20231027