Arnicare Leg Cramps

SPL v5

SPL

SPL Set ID 6b658f98-d6e9-9ac9-e053-2991aa0ab3b0

Route

ORAL

Published

Effective Date 2021-09-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Arnica Montana (9 [hp_C]) Zinc Oxide (3 [hp_C]) Lactic Acid, L-

Inactive Ingredients

Water Citric Acid Monohydrate Magnesium Stearate Dextrose Monohydrate Lemon Anhydrous Lactose

Identifiers & Packaging

Pill Appearance

Imprint: none Shape: round Color: white Size: 20 mm

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2018-06-15

Description

Active Ingredients** Arnica montana 9C HPUS (6.67 mg) Sarcolacticum acidum 3C HPUS (6.67 mg) Zincum oxydatum 3C (6.67 mg)

Medication Information

Indications and Usage

Uses*

temporarily relieves minor muscle pain from cramps, stiffness, and muscular fatigue due to prolonged exercise and physical activity

Dosage and Administration

Directions

Adults and children 12 years of age and older: Chew 1 tablet in the mouth immediately prior, during, and after physical activity every hour until symptoms improve, up to 10 tablets a day.

Children under 12 years of age: Not recommended.

Description

Active Ingredients** Arnica montana 9C HPUS (6.67 mg) Sarcolacticum acidum 3C HPUS (6.67 mg) Zincum oxydatum 3C (6.67 mg)

Section 42229-5

do not use if glued carton end flaps are open or if the plastic sleeve around the tube is broken or missing

retain carton for full drug facts

contains 1.6 g of sugar per tablet

store below 77° F (25°C)

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

Section 51727-6

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

Section 51945-4

Section 53413-1

Quesions or comments?

Arnicare.com

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Made in France

Distributed by: Boiron Inc.

Newtown Square, PA 19073-3267

Section 53414-9

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

Section 55105-1

Purpose*

Arnica montana 9C HPUS ... Temporarily relieves minor pain, stiffness & muscle soreness due to overexertion

Sarcolacticum acidum 3C HPUS ... Relieves muscle fatigue after prolonged exercise & muscle cramping

Zincum oxydatum 3C ... Relieves muscle cramping

Section 55106-9

Active Ingredients**

Arnica montana 9C HPUS (6.67 mg)

Sarcolacticum acidum 3C HPUS (6.67 mg)

Zincum oxydatum 3C (6.67 mg)

Structured Label Content

Indications and Usage (34067-9)

Uses*

temporarily relieves minor muscle pain from cramps, stiffness, and muscular fatigue due to prolonged exercise and physical activity

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and older: Chew 1 tablet in the mouth immediately prior, during, and after physical activity every hour until symptoms improve, up to 10 tablets a day.

Children under 12 years of age: Not recommended.

Section 42229-5 (42229-5)

do not use if glued carton end flaps are open or if the plastic sleeve around the tube is broken or missing

retain carton for full drug facts

contains 1.6 g of sugar per tablet

store below 77° F (25°C)

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Quesions or comments?

Arnicare.com

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Made in France

Distributed by: Boiron Inc.

Newtown Square, PA 19073-3267

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose*

Arnica montana 9C HPUS ... Temporarily relieves minor pain, stiffness & muscle soreness due to overexertion

Sarcolacticum acidum 3C HPUS ... Relieves muscle fatigue after prolonged exercise & muscle cramping

Zincum oxydatum 3C ... Relieves muscle cramping

Section 55106-9 (55106-9)

Active Ingredients**

Arnica montana 9C HPUS (6.67 mg)

Sarcolacticum acidum 3C HPUS (6.67 mg)

Zincum oxydatum 3C (6.67 mg)

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARNICA MONTANA", "unii": "O80TY208ZW", "classCode": "ACTIB", "strengthNumerator": "9", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTIC ACID, L-", "unii": "F9S9FFU82N", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "1"}, {"name": "DEXTROSE MONOHYDRATE", "unii": "LX22YL083G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEMON", "unii": "24RS0A988O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses* temporarily relieves minor muscle pain from cramps, stiffness, and muscular fatigue due to prolonged exercise and physical activity", "34068-7": "Directions Adults and children 12 years of age and older: Chew 1 tablet in the mouth immediately prior, during, and after physical activity every hour until symptoms improve, up to 10 tablets a day. Children under 12 years of age: Not recommended.", "42229-5": "do not use if glued carton end flaps are open or if the plastic sleeve around the tube is broken or missing retain carton for full drug facts contains 1.6 g of sugar per tablet store below 77° F (25°C)", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.", "51727-6": "citric acide, dextrose, lactose, magnesium stearate, natural lemon flavor", "53413-1": "Quesions or comments? Arnicare.com BoironUSA.com Info@Boiron.com 1-800-BOIRON-1 (1-800-264-7661) Made in France Distributed by: Boiron Inc. Newtown Square, PA 19073-3267", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose* Arnica montana 9C HPUS ... Temporarily relieves minor pain, stiffness & muscle soreness due to overexertion Sarcolacticum acidum 3C HPUS ... Relieves muscle fatigue after prolonged exercise & muscle cramping Zincum oxydatum 3C ... Relieves muscle cramping", "55106-9": "Active Ingredients** Arnica montana 9C HPUS (6.67 mg) Sarcolacticum acidum 3C HPUS (6.67 mg) Zincum oxydatum 3C (6.67 mg)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:27.749827 · Updated: 2026-03-14T23:16:50.125714