POWERFUL PAIN RELIEF- arnica montana cream

POWERFUL PAIN RELIEF by

Drug Labeling and Warnings

POWERFUL PAIN RELIEF by is a Homeopathic medication manufactured, distributed, or labeled by BACK TO NORMAL, LLC, HealthSpecialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

ARNICA MONTANA HPUS (1X)

PURPOSE

PURPOSE

FOR HEADACHES, MUSCLES & JOINTS

INDICATIONS & USAGE

USES: FIGHTS MUSCLE & JOINT PAIN, INFLAMMATION AND HEADACHES.

DOSAGE & ADMINISTRATION

DIRECTIONS: APPLY CREAM TO ENTIRE AREA OF PAIN LOCATION AND SURROUNDING

AREAS UNTIL ABSORBED INTO SKIN. MASSAGE INTO SKIN FOR BEST RESULT. USE AS NEEDED.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER, ISOPROPYLE PALMITATE,GLYCERY STEARATE, PEG-100 STEARATE,

NIACINAMIDE (VITAMIN B3), CETEARYL ALCOHOL, POLYSORBATE 60, PROPYLENE GLYCOL, STEARYL

ALCOHOL, GLYCERIN, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, LAVANDULA ANGUSTIFOLIA

(LAVENDER) FLOWER/LEAF/STEM, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, THYMUS VULGARIS

(THYME) FLOWER/LEAF EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, MENTHA PIPERITA (PEPPERMINT) LEAF

EXTRACT, EUCALYPTUS GLOVULUS LEAF EXTRACT, ORIGANUM MAJORANA LEAF EXTRACT, ZINGIBER OFFICINALE

(GINGER) ROOT EXTRACT, JUNIPERUS COMMUNIS FRUIT EXTRACT, SANTALUM ALBUM (SANDALWOOD) EXTRACT,

SALVIA SCLAREA (CLARY) EXTRACT, JUNIPERUS PHOENICEA GUM EXTRACT, POTASSIUM LACTATE, PHENOXYETHANOL,

BENZOIC ACID, ETHYLHEXYLGLYCERIN, GLYCERETH-2 COCOATE, HYDROXYPROPYL METHYLCELLULOSE, ACRYLATES/

C10-30 ALKYL ACRYLATE CROSSPOLYMER, FRAGRANCE, GLUCONOLACTONE, SODIUM BENZOATE, ALOE BARBADENSIS

LEAF JUICE

WARNINGS

WARNING: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES, DAMAGED SKIN OR WOUNDS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POWERFUL PAIN RELIEF 
arnica montana cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70992-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
NIACINAMIDE (UNII: 25X51I8RD4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
CHAMOMILE (UNII: FGL3685T2X)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
ROSEMARY (UNII: IJ67X351P9)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
GINGER (UNII: C5529G5JPQ)
JUNIPER BERRY (UNII: O84B5194RL)
SANDALWOOD (UNII: 3641YW25N2)
CLARY SAGE (UNII: U3HSK5JC0Q)
JUNIPERUS PHOENICEA RESIN (UNII: BZS0ODH12N)
POTASSIUM LACTATE (UNII: 87V1KMK4QV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70992-101-52	1 in 1 BOX	09/21/2016
1	NDC: 70992-101-12	57 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/21/2016

Labeler - BACK TO NORMAL, LLC (056034702)

Establishment
Name	Address	ID/FEI	Business Operations
HealthSpecialty		794053863	manufacture(70992-101)