MEIJER ULTRA STRENGTH PAIN RELIEVING TOPICAL ANALGESIC (camphor- synthetic, menthol, unspecified form, and methyl salicylate cream

Meijer Ultra Strength Pain Relieving by

Drug Labeling and Warnings

Meijer Ultra Strength Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution, INC, Garcoa, Inc., Sigan Industries INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Camphor 4%	Topical analgesic
Menthol 10%	Topical analgesic
Methyl salicylate 30%	Topical analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with

• arthritis
• simple backache
• strains
• sprains
• bruises

Warnings

For external use only.

ALLERGY ALERT if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. Avoid contact with the eyes and mucous membranes.

Do not use

• for arthritis-like conditions in children under 12. Consult a doctor.
• with a heating pad
• on wounds or damaged skin

If pregnant or breastfeeding ask a health professional before use.

When using this product

• use only as directed
• do not swallow
• do not bandage tightly

Stop 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 (1-800-222-1222) right away.

Directions

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: consult a doctor.

Other information

Store at room temperature

Inactive ingredients

carbomer, disodium EDTA, glyceryl stearate SE, lanolin, polysorbate 80, potassium hydroxide, stearic acid, triethanolamine, water.

Questions or comments?

1-866-567-8600

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DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

meijer®

Compare to Ultra Strength
BENGAY® Active
Ingredients*

NDC: 79481-1220-1

ULTRA
STRENGTH

pain
relieving
cream

Camphor 4% | Menthol 10% |
Methyl Salicylate 30%

For Arthritis, Simple
Backache, Strains,
Sprains, and Bruises

Non-Greasy

NET WT 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

MEIJER ULTRA STRENGTH PAIN RELIEVING   TOPICAL ANALGESIC
camphor (synthetic), menthol, unspecified form, and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79481-1220
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, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Lanolin (UNII: 7EV65EAW6H)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Potassium Hydroxide (UNII: WZH3C48M4T)
Stearic Acid (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79481-1220-1	1 in 1 CARTON	11/30/2020
1		113 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	11/30/2020

Labeler - Meijer Distribution, INC (006959555)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(79481-1220)