Muellergesic (Menthol And Camphor (Synthetic)) Cream [Mueller Sports Medicine Llc] -

MUELLERGESIC (MENTHOL AND CAMPHOR (SYNTHETIC)) CREAM [MUELLER SPORTS MEDICINE LLC]
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NDC	52564-312-01, 52564-312-02
Set ID	1dc6babe-4fac-4542-8954-374d078f4dbc
Category	HUMAN OTC DRUG LABEL
Packager	Mueller Sports Medicine LLC
Generic Name
Product Class
Product Number
Application Number	PART348

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredient Purpose
Menthol 12% Pain Relief
Camphor 6% Pain Relief
Uses
for the temporary relief of minor aches and pains of muscles and joints associated with
- simple backache
- arthritis
- strains
- sprains
Warnings
For external use only.
- do not apply to wounds or damaged skin
- do not bandage tightly
- do not use with heating pad, pack, wrap, hot water bottle or any heating element.
When using this product do not get into eyes
- avoid contact with other mucous membranes
Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or 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
- if pregnant or nursing, seek the advice of a health professional before using
Directions
- Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
- Children under 12 years of age consult a physician
- Apply a thin layer to affected area not more than 3 to 4 times daily
- Gently massage into the skin until fully absorbed
- Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
Inactive ingredients

Water (Aqua), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate
Questions or comments?

Call 1-800-356-9522 or Email us at sportcare@muellersportsmed.com
SPL UNCLASSIFIED SECTION

Extremely Flammable:
Keep from heat and flame
PRINCIPAL DISPLAY PANEL - 106 g Bottle Label
MUELLER®

Muellergesic®
Cream
topical analgesic

Cooling Menthol &
Camphor relieves
muscle and joint pain

HELPS TO RELIEVE PAIN
ASSOCIATED WITH
- Strains
- Sprains
- Muscle Aches & Pain
- Arthritis
- Joint Pain
Timed-Release
IcePearls™

6h

NET WT 3.75 OZ (106 g)

31200 LBL31200A - 9.16

Active ingredient	Purpose
Menthol 12%	Pain Relief
Camphor 6%	Pain Relief

INGREDIENTS AND APPEARANCE

MUELLERGESIC
menthol and camphor (synthetic) cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52564-312
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	12.72 g in 106 g
Camphor (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET)	Camphor (synthetic)	6.3 g in 106 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEPPERMINT OIL (UNII: AV092KU4JH)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
LINSEED OIL (UNII: 84XB4DV00W)
ACAI OIL (UNII: Z0W6766A2W)
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
ROSEMARY OIL (UNII: 8LGU7VM393)
LAURYL LAURATE (UNII: GPW77G0937)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
ETHYL MENTHANE CARBOXAMIDE, 1R,3R,4S (UNII: 3NJ8V2450N)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
STARCH, CORN (UNII: O8232NY3SJ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52564-312-02	106 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/01/2016
2	NDC:52564-312-01	106 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/25/2014	03/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	06/25/2014

Labeler - Mueller Sports Medicine LLC (006426316)

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