Cvs Arnica Gel
FDA Label NDC 66902-778

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Essentials, Inc. for the product Cvs Arnica (NDC 66902-778). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose*, uses*, warnings, otc - when using, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Arnica Montana 1X HPUS-7%

Purpose*

Bruises & Muscle Soreness

Uses*

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

Warnings

For external use only

Otc - When Using

When using this product

Use only as directed

  • do not use with other topical products.
  • do not bandage tightly or use a heating pad.

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Directions

Adults and Children 12 years and older:

  • Apply & gently massage painful or bruised areas
  • Repeat as needed, no more than 4 times 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.

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.

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.

    Principal Display Panel (73 g Carton Label)

    Principal Display Panel (73 g Carton 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 Tube Label)

    Principal Display Panel (73 g Tube Label)

* Please review the disclaimer below.