Equate Arnica Pain Relieving Gel
FDA Label NDC 49035-673

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Equate Arnica Pain Relieving (NDC 49035-673). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient‡, purpose**, uses**, warnings, when using this product, flammable, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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.

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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.

      Principal Display Panel (74 g Cylinder Carton)

      Principal Display Panel (74 g Cylinder Carton)

* Please review the disclaimer below.