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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X] in 1 g
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	2 [hp_X] in 1 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	2 [hp_X] in 1 g
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	2 [hp_X] in 1 g
RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (RHODODENDRON TOMENTOSUM LEAFY TWIG - UNII:877L01IZ0P)	RHODODENDRON TOMENTOSUM LEAFY TWIG	2 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	yellow (Light Yellow to Light Tan)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54973-3203-1	1 in 1 CARTON	08/27/2018
1		70.9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:54973-3203-2	10 g in 1 PACKET; Type 0: Not a Combination Product	08/27/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/27/2018

Labeler - Hyland’s Inc. (008316655)

Name	Address	ID/FEI	Business Operations
Establishment
Hyland's Inc		008316655	manufacture(54973-3203) , label(54973-3203) , pack(54973-3203)

Hyland's Naturals Muscle Therapy with Arnica Pain Relief Gel