Active Ingredient
Arnica montana: 1X – 7%
Ruta graveolens: 2%
Symphytum Officinale (Comfrey root): 2%
Mentha Piperita: 1.25%
Relieveit Spraingo Gel
FDA Label NDC 58133-950
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 Spraingo Gel (NDC 58133-950). 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
Significantly reduces swelling and pain
associated with acute sprains, strains
and muscle overexertion. Reduces
discoloration from bruising.
Uses:
Sprains, Strains, Muscle/Tendon
Pulls, Tendonitis
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 any of this product’s
active or inactive ingredients • do not apply
bandage tightly or use heating pad • do not
resume normal activity without the advice of a
- medical professionall
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® SprainGo 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:
Harpagophytum procumbens, Carbomer 934P,
Cyclomethicone, C13/14 Isoparaffin, Ethyl Alcohol,
Eucalyptus Oil, Glycerin,
Hydroxypropylcellulose, Isopropyl Myristate, Juniper
Oil, Laureth-7, Polyacrylamide, Polyethylene Glycol
3350, Polysorbate 80, Propyl Gallate, Propylene
Glycol, Purified Water, Resin, Sodium Hydroxide,
Sorbic Acid, Wintergreen Oil 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
7 days
If Pregnant Or Breast Feeding:
ask a health professional before use
Other Information
Store at 68-77°F (20-25°C)
Principal Display Panel And Drug Facts
Package Label (Relieveit Spraingo Gel 18sept2018)
* Please review the disclaimer below.
