STEUARTS PAIN FORMULA- arnica montana flower and comfrey leaf cream

Steuarts Pain Formula by

Drug Labeling and Warnings

Steuarts Pain Formula by is a Homeopathic medication manufactured, distributed, or labeled by Steuart Laboratories INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Arnica Montana 1X HPUS 7%	Pain relief, swelling, discoloration from bruising
Comfrey (Symphytum Officinale) 1X HPUS 5%	Healing, Pain relief

Uses

• For the temporary relief of minor aches and pains of joint and muscle pain associated with arthritis, simple backache, strains and bruises.

Warnings

For external use only

Allergy Alert

If prone to allergic reactions apply on small area, consult a doctor before use.

When using this product

• use only as directed
• do not use on open wounds or broken skin.

Stop use and ask doctor if

• condition worsens
• redness is present
• irritation develops

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

Keep out of reach of children. If ingested drink copious amounts of water.

Directions

• Massage a thin layer into the skin over the affected area every 4 to 8 hours or as needed
• store at room temperature

Inactive ingredients

aloe barbadensis (aloe vera) leaf extract, carbopol gel former, cetyl alcohol, DI water, glucosamine sulfate, glycerin, histamine dihydrochloride, Sodium EDTA, Ethylhexylglycerin, Phenoxyethanol, methylsulfonylmethane (MSM/DMSO2), milk isolates, olive oil, safflower oil, salix alba (willow) bark extract, triethanolamine.

PRINCIPAL DISPLAY PANEL - 142 gr Bottle Label

STEUART'S

Pain
Formula

PAIN RELIEF CREAM

2
OF NATURE'S
STRONGEST
PAIN RELIEVERS

Arnica
Comfrey

Net Wt 5 oz (142 gr)

INGREDIENTS AND APPEARANCE

STEUARTS PAIN FORMULA 
arnica montana flower and comfrey leaf cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63374-507
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Arnica Montana Flower (UNII: OZ0E5Y15PZ) (Arnica Montana Flower - UNII:OZ0E5Y15PZ)	Arnica Montana Flower	1 [hp_X]  in 1 g
Comfrey Leaf (UNII: DG4F8T839X) (Comfrey Leaf - UNII:DG4F8T839X)	Comfrey Leaf	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Cetyl Alcohol (UNII: 936JST6JCN)
Glycerin (UNII: PDC6A3C0OX)
Safflower oil (UNII: 65UEH262IS)
Edetate Sodium (UNII: MP1J8420LU)
Ethylhexylglycerin (UNII: 147D247K3P)
Salix Alba Bark (UNII: 205MXS71H7)
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
Water (UNII: 059QF0KO0R)
Histamine Dihydrochloride (UNII: 3POA0Q644U)
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: 809Y72KV36)
Olive Oil (UNII: 6UYK2W1W1E)
Whey (UNII: 8617Z5FMF6)
Phenoxyethanol (UNII: HIE492ZZ3T)
Trolamine (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63374-507-01	142 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/2016
2	NDC: 63374-507-02	51 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		09/01/2016

Labeler - Steuart Laboratories INC (116952121)

Establishment
Name	Address	ID/FEI	Business Operations
Steuart Laboratories INC		786086462	MANUFACTURE(63374-507)