EQUATE ARNICA PAIN RELIEVING- arnica montana whole gel

Equate Arnica Pain Relieving by

Drug Labeling and Warnings

Equate Arnica Pain Relieving by is a Homeopathic medication manufactured, distributed, or labeled by Walmart, Inc., Garcoa, Inc., Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient‡

Arnica Montana 1X HPUS 7%
The letters HPUS indicate that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

Purpose**

Relieve muscle pain and stiffness, swelling from injuries, discoloration from bruises

Uses**

According to homeopathic principles, the active ingredient in this product temporarily relieves minor symptoms such as:

• ♦ bruising and swelling
• ♦ sprains
• ♦ backaches
• ♦ muscular aches and pains
• ♦ strains
• ♦ stiffness

Warnings

For external use only. Do not use on damaged skin, open wounds, or mucous membranes. Test on a small patch of skin before applying generously.

• ♦ According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
• ♦ Avoid contact with eyes.
• ♦ Do not use if you are allergic to Arnica montana (Asteracea flower) or any of this product's inactive ingredients.
• ♦ Do not bandage tightly or use with a heating pad.
• ♦ Do not use with heating pads or other heating devices.
• ♦ If conditions worsen or if symptoms persist for more than 72 hours or clear up and occur again within a few days, discontinue use of this product and consult a physician.

When using this product

• ♦ use only as directed
• ♦ avoid contact with eyes and mucous membranes
• ♦ if redness is present, discontinue use and consult a doctor
• ♦ if skin irritation occurs, discontinue use
• ♦ a transient burning sensation may occur upon application but generally disappears in several days.

Flammable

• ♦ keep away from fire or flame

If pregnant, trying to get 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 immediately.

Directions

For adults and children 2 years of age and older:

• ♦ Apply a thin layer to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed.

Other information

• ♦ Active ingredients are manufactured according to homeopathic principles.
• ♦ Store at room temperature

Inactive ingredients

alcohol denat., capsaicin, carbomer, glycerin, sodium hydroxide, water.

Questions or comments?

1-888-287-1915

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DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

† These uses have not been evaluated by the Food and Drug Administration.
‡ X is the symbol for the homeopathic dilution 10:1
** Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PRINCIPAL DISPLAY PANEL - 74 g Cylinder Carton

NDC: 49035-673-01

equate™

Compare to
Arnicare®
Gel active
ingredient*

with Capsaicin

Arnica

Pain Relieving†**
Gel

Homeopathic
Medicine

Relieves:†**

• Muscle pain & stiffness
• Swelling from injuries
• Bruising

• Non-greasy
• Fast-absorbing
• Unscented
• Paraben-free

No Mess
Roll-On
Applicator

NET WT
2.6 OZ
(74g)

**Claims based on traditional homeopathic practice,
not accepted medical evidence. Not FDA evaluated.

INGREDIENTS AND APPEARANCE

EQUATE ARNICA PAIN RELIEVING 
arnica montana whole gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-673
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW)	ARNICA MONTANA WHOLE	70 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
CAPSAICIN (UNII: S07O44R1ZM)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-673-01	1 in 1 CARTON	04/30/2020
1		74 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		04/30/2020

Labeler - Walmart, Inc. (051957769)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	MANUFACTURE(49035-673)