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:

• muscle sprains
• muscle strains
• simple backache
• bruises
• arthritis
• cramps

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 damaged skin
• with a heating pad

WHEN USING

When using this product

• ​avoid contact with eyes or mucous membranes
• do not bandage tightly

ASK DOCTOR

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

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

childen under 12 years of age: ask a doctor

DOSAGE & ADMINISTRATION

Other Information

• store at room temperature 20-25ºC (68-77ºF)

INACTIVE INGREDIENT

Inactive ingredients carbomer, cetostearyl alcohol, cetyl esters wax, polysorbate 60, purified water, steareth-20, stearic acid, trolamine

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: 41250-858
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
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
STEARETH-20 (UNII: L0Q8IK9E08)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETYL ESTERS WAX (UNII: D072FFP9GU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-858-35	1 in 1 CARTON	07/02/2020
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	07/02/2020

Labeler - Meijer, Inc. (006959555)