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

Equate Cold Therapy Pain Relieving Roll-on by

Drug Labeling and Warnings

Equate Cold Therapy Pain Relieving Roll-on by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, 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 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 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 (1-800-222-1222) immediately.

Directions

• ♦ Adults and children 2 years of age and older: Apply to affected area not more than 3-4 times daily.
• ♦ Children under 2 years of age: Consult a doctor.

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?

1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label

NDC: 79903-022-01

equate™

Compare
to Biofreeze®
active
ingredient*

Cold Therapy
Pain Relieving
Gel

Menthol 4% Topical
Analgesic

• For backache, muscle
  pain, joint pain
• Soothing menthol
• Hands-free roll-on
  applicator

2.5 FL OZ (74mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79903-022
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: 79903-022-01	74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/14/2021

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(79903-022)