Muscle Therapy with Arnica Pain Relief Gel: Homeopathic Product Information

MUSCLE THERAPY WITH ARNICA PAIN RELIEF GEL- arnica montana, bellis perennis, hypericum perforatum, ruta graveolens flowering top and rhododendron tomentosum leafy twig gel
Hyland’s

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Purpose

Temporarily relieves symptoms of pain, bruising, muscle soreness and
swelling due to overexertion or injury.

Drug Facts

Active ingredients

Active ingredients Purpose
Arnica Montana 1X HPUS bruising, swelling, stiffness, muscle soreness and pain
Bellis Perennis 2X HPUS sprains, swelling and sore muscles
Hypericum Perforatum 2X HPUS radiating pains
Ledum Palustre 2X HPUS pain
Ruta Graveolens 2X HPUS sprains and twist

“HPUS” is the Homeopathic Pharmacopoeia of the United States.

Uses

Temporarily relieves the symptoms of pain, bruising, muscle soreness and swelling due to overexertion or injury.

Warnings

For external use only. Keep away from eyes.

Do not use

on open wounds.

Stop use and ask a doctor if

■ pain gets worse or lasts more than 7 days.
■ new symptoms occur. ■ redness or swelling persists or worsens.

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children.

Directions

Adults and children 6 years and over: ■ Apply liberally to affected area. ■ Repeat until relieved, up to 4 times per day. ■ Do not use other than directed.

Inactive ingredients

Carbopol ® Ultrez 21 Polymer, Ethyl Alcohol, Purified Water, Sodium Hydroxide

Questions?

www.hylands.com or (800) 624-9659

HOMEOPATHIC ACTIVE INGREDIENTS 20%

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

Principal Display Panel — 70.9 Grams Gel Tube Carton

Hyland’s

NATURALS™

MUSCLE

THERAPY

-WITH ARNICA-

PAIN RELIEF GEL*

SORENESS SWELLING

STIFFNESS BRUISING

HOMEOPATHIC

2.5 OZ. (70.9 GRAMS)

Carton
(click image for full-size original)
MUSCLE THERAPY WITH ARNICA PAIN RELIEF GEL
arnica montana,bellis perennis,hypericum perforatum,ruta graveolensflowering top and rhododendron tomentosum leafy twig gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3203
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 1 [hp_X] in 1 g
BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS 2 [hp_X] in 1 g
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM 2 [hp_X] in 1 g
RUTA GRAVEOLENS FLOWERING TOP (RUTA GRAVEOLENS FLOWERING TOP) RUTA GRAVEOLENS FLOWERING TOP 2 [hp_X] in 1 g
RHODODENDRON TOMENTOSUM LEAFY TWIG (RHODODENDRON TOMENTOSUM LEAFY TWIG) RHODODENDRON TOMENTOSUM LEAFY TWIG 2 [hp_X] in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
SODIUM HYDROXIDE
Product Characteristics
Color yellow (Light Yellow to Light Tan) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3203-1 1 TUBE in 1 CARTON contains a TUBE
1 70.9 g in 1 TUBE This package is contained within the CARTON (54973-3203-1)
2 NDC:54973-3203-2 10 g in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 08/27/2018
Labeler — Hyland’s (028570695)
Establishment
Name Address ID/FEI Operations
Standard Homeopathic Company 080253323 manufacture (54973-3203), label (54973-3203), pack (54973-3203)
Establishment
Name Address ID/FEI Operations
Lifetech Resources, LLC 622559110 manufacture (54973-3203), pack (54973-3203), label (54973-3203)

Revised: 12/2021 Hyland’s

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