BACK TO NORMAL ARNICA- arnica montana cream
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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.

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BACK TO NORMAL (as PLD) - ARNICA CREAM (70992-101) - DELIST

ACTIVE INGREDIENTS

ARNICA MONTANA HPUS (1X)

PURPOSE

FOR HEADACHES, MUSCLES & JOINTS

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

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 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

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

KEEP OUT OF REACH OF CHILDREN.

PAIN RELIEF INSIDE LABEL PAIN RELIEF OUTSIDE LABEL

BACK TO NORMAL ARNICA
arnica montana cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70992-101
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 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70992-101-52	1 in 1 BOX	09/21/2016	12/31/2023
1	NDC:70992-101-12	57 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/21/2016	12/31/2023

Labeler - BACK TO NORMAL, LLC (056034702)

Revised: 4/2024

Document Id: 150f6a73-83d8-8739-e063-6294a90a51b5

Set id: ae9147a5-e586-47e7-9007-0f6800a27d95

Version: 7

Effective Time: 20240401

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