MEIJER MUSCLE ULTRA- camphor, menthol, methyl salicylate cream

MEIJER MUSCLE ULTRA by

Drug Labeling and Warnings

MEIJER MUSCLE ULTRA by is a Otc medication manufactured, distributed, or labeled by MEIJER, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                             Purpose

Camphor 4%..................................................................................Topical analgesic

Menthol 10%..................................................................................Topical analgesic

Methyl Salicylate.............................................................................Topical analgesic

PURPOSE

Uses

Temporarily relieves the minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

WARNINGS

Warnings

For external use only

Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

DO NOT USE

Do not use

• on wounds or damages skin
• with a heating pad
• on a child under 12 years of age with arthritis like conditions

ASK DOCTOR

Ask a doctor before use

if you have redness over the affected area

WHEN USING

When using this product

• do not use otherwise than as directed
• avoid contact with eyes or mucous membranes
• do not bandage tightly

STOP USE

Stop use and ask a doctor if

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

INDICATIONS & USAGE

Directions

• use only as directed
• adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

Store between 20 o and 25 o C (68 o and 77 oF)

INACTIVE INGREDIENT

Inactive ingredients

glycerin, isopropyl myristate, lanolin, methylparaben, petrolatum, polysorbate 60, potassium cetyl phosphate, propylparaben, sorbitan monostearate, stearyl alcohol, water

DOSAGE & ADMINISTRATION

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Made in South Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEIJER MUSCLE ULTRA 
camphor, menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	300 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-253-57	1 in 1 CARTON	10/11/2016
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	08/31/2012

Labeler - MEIJER, INC. (006959555)