Active Ingredient
Arnica montana 1X HPUS: 7%
Relieveit Gel
FDA Label NDC 58133-951
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Specialty Labs, Inc. for the product Relieveit Gel (NDC 58133-951). 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:, when using this product:, otc - keep out of reach of children, directions:, other ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Arthritis • bursitis • Fibromyalgia • Tendonitis • Joint pain/discomfort
- Sciatica • Swelling • Muscle pulls/aches/soreness
Uses:
Arthritis • Osteoarthritis • Backaches • Bursitis •
Fibromyalgia • Tendonitis • Joint pain/discomfort
• Sciatica • Swelling
Warnings:
for external use only
When Using This Product:
use only as directed • avoid contact with eyes
or mucous membranes • do not apply to open
wounds, damaged, or very sensitive skin • do
not use if you are allergic to Arnica montana or to any of this product’s
inactive ingredients • do not apply bandage tightly or use heating pad
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact the
Poison Control Center right away.
Directions:
Adults and children 2 years and over:
•Shake well before using •Apply a sufficient
amount of RelieveIt® Gel to cover the
affected area • Repeat as needed • After
applying, wash hands with soap and water
Children under 2: consult a doctor
Other Ingredients:
Calendula officinalis, Carbomer 934P, Cyclomethicone, Ethyl Alcohol,
Eucalyptus, Glycerin, Hydroxypropyl Cellulose,
Isopropyl Myristate, Juniper Oil, Laureth-7, Polyacrylamide, Polyethylene
Glycol 3350, Polysorbate 80, Propyl Gallate,
Propylene Glycol, Purified Water, Resin, Sodium
Hydroxide, Sorbic Acid, Wintergreen, and Xanthan Gum.
*These “Uses” have not been evaluated by the
Food & Drug Administration.
Stop Use And Ask A Doctor If:
excessive redness or irritation is present •
condition worsens • pain persists for more than
3 days
If Pregnant Or Breast Feeding:
ask a health professional before use
Other Information
Do not use if glued carton end flaps are open or if tube seal is broken.
Store at 68-77°F (20-25°C)
* Please review the disclaimer below.
