Arnicare Gel Value Pack

Arnicare Gel Value Pack
SPL v13
SPL
SPL Set ID bc842386-e41c-4303-b27f-1642771ed1a4
Routes
ORAL TOPICAL
Published
Effective Date 2020-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (30 [hp_C])
Inactive Ingredients
Sucrose Lactose Alcohol Dimethicone Water Sodium Hydroxide Carbomer Homopolymer Type C

Identifiers & Packaging

Pill Appearance
Imprint: ; Shape: round Color: white Size: 4 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2008-11-01

Description

Active ingredients** Arnicare Gel: Arnica Montana 1X HPUS 7% Arnica 30C pellets: (in each pellet) Arnica Montana 30C HPUS (0.443 mg) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Warnings and Precautions

Arnicare Gel: For external use only.

Indications and Usage

Uses*

temporarily relieves muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls

reduces symptoms of bruising such as:

  • pain
  • swelling
  • discoloration
Dosage and Administration

Directions

ARNICARE GEL: Apply a thin layer of Arnicare Gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare Gel.

ARNICA 30C PELLETS: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Description

Active ingredients** Arnicare Gel: Arnica Montana 1X HPUS 7% Arnica 30C pellets: (in each pellet) Arnica Montana 30C HPUS (0.443 mg) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 42229-5

do not use if glued carton end flaps are open, if the tube seal is broken, or if pellet dispenser seal is broken

Quickly absorbed, non-greasy, fragrance-free, non-drowsy, no known drug interactions

Pain Relief*

Muscle Pain & Stiffness Swelling from Injuries Bruises*

Local & General Pain

Combine for Total Relief

Gel: 1 tube 2.6 oz (75g)

Pellets: + approx. 80 pellets

How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.



Section 50566-9

Stop use and ask a doctor if

condition persists for more than 3 days or worsens

symptoms clear up and occur again within a few days.

ARNICA 30C PELLETS:

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

Section 50567-7

When using this product

  • avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
  • use only as directed
  • dryness or irritation may occur
  • do not tightly wrap or bandage the treated area
  • do not apply heat or ice to the treated area immediately before or after use.
Section 50570-1

Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.

Section 51727-6

ARNICARE GEL: alcohol, carbomer, purified water, sodium hydroxide

ARNICA 30C PELLETS: lactose, sucrose.

Section 51945-4

Section 53413-1

Arnicare.com

BoironUSA.com

[email protected]

1-800-BOIRON-1

1-800-264-7661

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Purpose*

Arnicare Gel: Arnica Montana 1X HPUS 7% ..... Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises

Arnica 30C Pellets: Arnica montana 30C HPUS .......... Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises

Section 55106-9

Active ingredients**

Arnicare Gel: Arnica Montana 1X HPUS 7%

Arnica 30C pellets: (in each pellet) Arnica Montana 30C HPUS (0.443 mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Structured Label Content

Indications and Usage (34067-9)

Uses*

temporarily relieves muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls

reduces symptoms of bruising such as:

  • pain
  • swelling
  • discoloration
Dosage and Administration (34068-7)

Directions

ARNICARE GEL: Apply a thin layer of Arnicare Gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare Gel.

ARNICA 30C PELLETS: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Warnings and Precautions (34071-1)

Arnicare Gel: For external use only.

Section 42229-5 (42229-5)

do not use if glued carton end flaps are open, if the tube seal is broken, or if pellet dispenser seal is broken

Quickly absorbed, non-greasy, fragrance-free, non-drowsy, no known drug interactions

Pain Relief*

Muscle Pain & Stiffness Swelling from Injuries Bruises*

Local & General Pain

Combine for Total Relief

Gel: 1 tube 2.6 oz (75g)

Pellets: + approx. 80 pellets

How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.



Section 50566-9 (50566-9)

Stop use and ask a doctor if

condition persists for more than 3 days or worsens

symptoms clear up and occur again within a few days.

ARNICA 30C PELLETS:

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

Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
  • use only as directed
  • dryness or irritation may occur
  • do not tightly wrap or bandage the treated area
  • do not apply heat or ice to the treated area immediately before or after use.
Section 50570-1 (50570-1)

Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.

Section 51727-6 (51727-6)

ARNICARE GEL: alcohol, carbomer, purified water, sodium hydroxide

ARNICA 30C PELLETS: lactose, sucrose.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Arnicare.com

BoironUSA.com

[email protected]

1-800-BOIRON-1

1-800-264-7661

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose*

Arnicare Gel: Arnica Montana 1X HPUS 7% ..... Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises

Arnica 30C Pellets: Arnica montana 30C HPUS .......... Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises

Section 55106-9 (55106-9)

Active ingredients**

Arnicare Gel: Arnica Montana 1X HPUS 7%

Arnica 30C pellets: (in each pellet) Arnica Montana 30C HPUS (0.443 mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Advanced Ingredient Data


Raw Label Data

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