Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID e49ae317-a03d-4576-ba27-f661469584ed
Route
TOPICAL
Published
Effective Date 2021-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana Flower (1 [hp_X])
Inactive Ingredients
Caprylyl Glycol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Peg-8 Dimethicone Phenoxyethanol Alcohol Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2021-01-27 Until 2026-10-11

Description

Arnica Montana 1X HPUS-7%

Purpose

Bruises & Muscle Soreness


Medication Information

Purpose

Bruises & Muscle Soreness

Description

Arnica Montana 1X HPUS-7%

Uses*

Homeopathic remedy/medicine temporarily relieves muscle pain and stiffness due to minor injuries; reduces pain, swelling and discoloration from bruises.

Section 50565-1

Keep out of reach of children and pets, if swallowed, seek professional help and contact Poison Control Center right away.

Section 50567-7

When using this product

Use only as directed

  • do not use with other topical products.
  • do not bandage tightly or use a heating pad.
Section 53414-9

If pregnant or breast feeding, ask a physician before use.

Purpose*

Bruises & Muscle Soreness

Warnings

For external use only

Directions

Adults and Children 12 years and older:

  • Apply & gently massage painful or bruised areas
  • Repeat as needed, no more than 4times a day
  • Wash hands after each use with cold water
  • Store in a cool, dry area - close cap tight

Children under 12: Ask your doctor.

Active Ingredient

Arnica Montana 1X HPUS-7%

Other Information

Active ingredients are HPUS and manufactured according to homeopathic principles.

Inactive Ingredients

Caprylyl Glycol, Carbomer, PEG-8 Dimethicone, Phenoxyethanol, SDA 40-2 Alcohol, Sodium Hydroxide, Water.

Stop Use and Ask A Doctor If
  • a rash or other adverse reaction occurs.
  • symptoms worsen or persist for more than 7 days.
  • avoid contact with eyes or mucous membranes, damaged skin or wounds.
  • do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.
Principal Display Panel 73 G Tube Label

CVS

Health ®

Arnica Gel

RELIEF FOR PAIN,

STIFFNESS &

SWELLING*

Homeopathic

  • Absorbs quickly
  • Unscented
  • Non-greasy
  • Paraben free

NET WT

2.6 OZ

(73 g)

*Claims based on

traditional homeopathic

practice, not accepted

medical evidence. Not

FDA evaluated.

Principal Display Panel 73 G Carton Label

CVSHealth ®

Compare to the active ingredient

in Arnicare ®Gel**

Arnica Gel

RELIEF FOR PAIN, STIFFNESS & SWELLING*

Homeopathic

  • Absorbs quickly
  • Unscented
  • Non-greasy
  • Paraben free

Package Contains One Tube

NET WT 2.6 OZ (73 g)

*Claims based on traditional

homeopathic practice, not accepted

medical evidence. Not FDA evaluated.


Structured Label Content

Uses*

Homeopathic remedy/medicine temporarily relieves muscle pain and stiffness due to minor injuries; reduces pain, swelling and discoloration from bruises.

Section 50565-1 (50565-1)

Keep out of reach of children and pets, if swallowed, seek professional help and contact Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product

Use only as directed

  • do not use with other topical products.
  • do not bandage tightly or use a heating pad.
Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a physician before use.

Purpose*

Bruises & Muscle Soreness

Warnings

For external use only

Directions

Adults and Children 12 years and older:

  • Apply & gently massage painful or bruised areas
  • Repeat as needed, no more than 4times a day
  • Wash hands after each use with cold water
  • Store in a cool, dry area - close cap tight

Children under 12: Ask your doctor.

Active Ingredient (Active ingredient)

Arnica Montana 1X HPUS-7%

Other Information (Other information)

Active ingredients are HPUS and manufactured according to homeopathic principles.

Inactive Ingredients (Inactive ingredients)

Caprylyl Glycol, Carbomer, PEG-8 Dimethicone, Phenoxyethanol, SDA 40-2 Alcohol, Sodium Hydroxide, Water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor If)
  • a rash or other adverse reaction occurs.
  • symptoms worsen or persist for more than 7 days.
  • avoid contact with eyes or mucous membranes, damaged skin or wounds.
  • do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.
Principal Display Panel 73 G Tube Label (Principal Display Panel - 73 g Tube Label)

CVS

Health ®

Arnica Gel

RELIEF FOR PAIN,

STIFFNESS &

SWELLING*

Homeopathic

  • Absorbs quickly
  • Unscented
  • Non-greasy
  • Paraben free

NET WT

2.6 OZ

(73 g)

*Claims based on

traditional homeopathic

practice, not accepted

medical evidence. Not

FDA evaluated.

Principal Display Panel 73 G Carton Label (Principal Display Panel - 73 g Carton Label)

CVSHealth ®

Compare to the active ingredient

in Arnicare ®Gel**

Arnica Gel

RELIEF FOR PAIN, STIFFNESS & SWELLING*

Homeopathic

  • Absorbs quickly
  • Unscented
  • Non-greasy
  • Paraben free

Package Contains One Tube

NET WT 2.6 OZ (73 g)

*Claims based on traditional

homeopathic practice, not accepted

medical evidence. Not FDA evaluated.


Advanced Ingredient Data


Raw Label Data

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