MEIJER ROLL-ON COLD THERAPY PAIN RELIEVING TOPICAL ANALGESIC- menthol, unspecified form gel

meijer ROLL-ON Cold Therapy Pain Relieving by

Drug Labeling and Warnings

meijer ROLL-ON Cold Therapy 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

Menthol 4%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only

Ask a doctor before use if you have sensitive skin.

When using this product

• ⬥ Avoid contact with the eyes
• ⬥ Do not apply to wounds or damaged skin
• ⬥ Do not use with other ointments, creams, sprays or liniments
• ⬥ Do not apply to irritated skin or if excessive irritation develops
• ⬥ Do not bandage tightly
• ⬥ Wash hands after use with cool water
• ⬥ Do not use with heating pads or heating devices.

Stop use and consult a doctor if

• ⬥ condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Flammable

• ⬥ keep away from excessive heat or open flame.

If pregnant or breastfeeding, ask a health professional before use.

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

Directions

• ⬥ Adults and children 6 years of age and older: Apply to affected area not more than 3-4 times daily. Massage not necessary
• ⬥ Children under 6 years of age: Do Not Use.

Other information

store in a cool dry place with lid closed tightly.

Inactive ingredients

aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5.

Questions or comments?

1-866-567-8600

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label

meijer®

ROLL-ON
Cold Therapy
Pain Relieving
Gel

COMPARE TO
BIOFREEZE®
ROLL-ON PAIN RELIEF
ACTIVE INGREDIENT*

MENTHOL 4% |
TOPICAL ANALGESIC

For arthritis, back pain, sore
muscles & joints

Hands-free roll-on applicator

Paraben free

2.5 FL OZ (74 mL)

INGREDIENTS AND APPEARANCE

MEIJER ROLL-ON COLD THERAPY PAIN RELIEVING   TOPICAL ANALGESIC
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79481-0088
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Alcohol (UNII: ND2M416302)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Sodium Hydroxide (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
Water (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79481-0088-1	74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	11/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M017	11/03/2023

Labeler - MEIJER DISTRIBUTION, INC (006959555)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC		255106239	MANUFACTURE(79481-0088) , LABEL(79481-0088) , PACK(79481-0088)