ARNICARE LEG CRAMPS- arnica montana, lactic acid, l-, zinc oxide tablet

Arnicare Leg Cramps by

Drug Labeling and Warnings

Arnicare Leg Cramps by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Arnica montana 9C HPUS

Sarcolacticum acidum 3C HPUS

Zincum oxydatum 3C

PURPOSE

Arnica montana 9C HPUS Relieves muscle fatigue causing or caused by cramps

Sarcolacticum acidum 3C HPUS Relieves pain and stiffness from muscular overexertion

Zincum oxydatum 3C Relieves day and night muscle cramps

INDICATIONS & USAGE

Temporarily relieves day and night cramps and spasms in calves, legs, thighs, and arms and cramps from muscular overexertion.

WARNINGS

STOP USE

Stop use and ask a doctor if symptoms persist fro more than 3 days or worsen

ASK DOCTOR

Ask a doctor before use if you have diabetes (each tablet contains 1.6g dextrose)

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

Adults and children age 12 and up: chew or allow 1 tablet to dissolve in the mouth at bedtime and if cramps occur, up to 6 times per day. Take before, during, and after exercise. Contains dextrose; consider rinsing mouthwith water before going to sleep.

SPL UNCLASSIFIED SECTION

stay hydrated, practice regular physical activity, store at 68-77F (2-25C)

INACTIVE INGREDIENT

dextrose, lactose, magnesium stearate, citric acid, natural lemon flavor

SPL UNCLASSIFIED SECTION

These "Uses" have not been evaluated by the Food and Drug Administration.

C, CK, and X are homeopathic dilutions: see BoironUSA.com/info for details

QUESTIONS

Arnicare.com

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1

(1-800-264-7661)

Distributed by: Boiron Inc.

6 Campus Blvd.

Newtown Square, PA 19073-3267

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICARE LEG CRAMPS 
arnica montana, lactic acid, l-, zinc oxide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9073
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	9 [hp_C]
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3 [hp_C]
LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N)	LACTIC ACID, L-	3 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
LEMON (UNII: 24RS0A988O)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	20mm
Flavor	LEMON	Imprint Code	none
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9073-90	33 in 1 PACKAGE	06/15/2018
1		11 in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/15/2018

Labeler - Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9073)