MEIJER COLD AND HOT THERAPY- menthol, methyl salicylate cream

MEIJER COLD AND HOT THERAPY by

Drug Labeling and Warnings

MEIJER COLD AND HOT THERAPY 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

Menthol 10%............................................................................................Topical Analgesic

Methyl Salicylate 30%...............................................................................Topical Analgesic

PURPOSE

Uses

temporarily relieves minor pain associated with:

• Arthritis
• Simple backache
• Muscle strains
• Sprains
• Bruises
• Cramps

WARNINGS

Warning

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 damaged skin
• with a heating pad

WHEN USING

When using this product

• Do not bandage tightly
• Avoid contact with eyes or mucous membranes

STOP USE

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation occurs
• redness of the skin is present

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

INDICATIONS & USAGE

Directions Adults and children over 12 years

• use only as directed
• adults and children 12 years of age and older:
• apply generously to affected area
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary, but not more than 4 times daily
• children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

isopropyl myristate, lanolin, methylparaben, polysorbate 60, potassium cetyl phosphate, propylparaben, purified water, stearic acid, stearyl alcohol

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 COLD AND HOT THERAPY 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-254
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-254-35	1 in 1 CARTON	10/11/2016
1		35 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	11/30/2012

Labeler - MEIJER, INC. (006959555)