MEIJER PAIN RELIEVING BALM ANALGESIC- trolamine salicylate cream

Meijer Pain Relieving Balm by

Drug Labeling and Warnings

Meijer Pain Relieving Balm 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

Trolamine Salicylate 10%

Purpose

Topical analgesic

Uses

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

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

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

• Avoid contact with eyes
• Do not apply to wounds or damaged skin
• Do not bandage tightly
• Do not use with heating pads or heating devices
• If condition worsens, or if the symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older apply to affected area not more than 3 to 4 times daily. Children under 6 years of age: Do Not Use.

Other information

Store at room temperature

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, arnica montana flower extract, boswellia carterii oil, butyrospermum parkii (shea) butter, calophyllum inophyllum seed oil, caprylic/capric triglyceride, cetyl alcohol, curcuma longa (turmeric) root extract, ethylhexylglycerin, fragrance, glycerin, glyceryl stearate, harpagophytum procumbens root extract, isopropyl palmitate, macadamia ternifolia seed oil, menthol, olea europaea (olive) fruit oil, PEG-100 stearate, phenoxyethanol, propylene glycol, salix alba (willow) bark extract, sodium hyaluronate, sodium hydroxide, sodium PCA, stearic acid, theobroma cacao (cocoa) seed butter, water.

Questions or comments?

1-866-567-8600

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 113 g Jar Label

meijer®

TURMERIC INFUSED
pain relieving balm
Trolamine Salicylate 10%

Topical Analgesic

WITH TURMERIC,
BOSWELLIA OIL, TAMANU OIL
AND DEVIL'S CLAW

Helps relieve minor aches and pains
of muscles and joints associated with:

• backache
• bruises
• arthritis
• sprains
• strains

NET WT 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

MEIJER PAIN RELIEVING BALM   ANALGESIC
trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-356
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Trolamine Salicylate (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Trolamine Salicylate	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
SHEA BUTTER (UNII: K49155WL9Y)
TAMANU OIL (UNII: JT3LVK84A1)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Cetyl Alcohol (UNII: 936JST6JCN)
TURMERIC (UNII: 856YO1Z64F)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
Isopropyl Palmitate (UNII: 8CRQ2TH63M)
MACADAMIA OIL (UNII: 515610SU8C)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
OLIVE OIL (UNII: 6UYK2W1W1E)
PEG-100 Stearate (UNII: YD01N1999R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Propylene Glycol (UNII: 6DC9Q167V3)
SALIX ALBA BARK (UNII: 205MXS71H7)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Sodium Hydroxide (UNII: 55X04QC32I)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
Stearic Acid (UNII: 4ELV7Z65AP)
COCOA BUTTER (UNII: 512OYT1CRR)
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: 41250-356-01	113 g in 1 JAR; Type 0: Not a Combination Product	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	04/30/2020

Labeler - Meijer Distribution, INC (006959555)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(41250-356)