FDA Label for Australian Gold Aloe Freeze Gel With Lidocaine

View Indications, Usage & Precautions

Australian Gold Aloe Freeze Gel With Lidocaine Product Label

The following document was submitted to the FDA by the labeler of this product Prime Enterprises, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Principal Display Panel - 237 Ml  Bottle Label




EXOTIC BLEND

# 1 Fragrance

ALOE

FREEZE

GEL

With Lidocaine

Provides Instant Cooling Sensation

Topical Analgesic

Australian

Gold

237 mL / 8 Fl. Oz


Active Ingredients



Lidocaine Hydrochloride(0.5 %)


Purpose



External Analgesic


Indications



For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.


Warnings




Otc - When Using



Avoid contact with eyes.


Otc - Stop Use



If conditions worsens, or is symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.


Otc - Keep Out Of Reach Of Children



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


Directions



  • Adults and children 2 years of age and older:
  •     Apply to afftected area not more than 3 to 4 times daily.

    • Children under 2 years of age:
    •     consult a doctor.


Inactive Ingredients



Allantoin, Aloe Barbadensis Leaf Juice, Blue 1 (Cl 42090), Caprylyl Glycol, Carbomer, Citrus Limon (Lemon Bioflavonoids) Peel Extract, Glycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Hexylene Glycol, Mentha Viridis (Spearmint) Leaf Oil, Polysorbate 20, Propylene Glycol, Symphytum Officinale (Comfrey) Leaf Extract, Tilia Cordata Flower Extract, Tocophenyl Acetate, Triethanolamine, Water (Aqua)


Questions Or Comments?



Call toll free 1-855-LIV-GOLD (546-4653)


* Please review the disclaimer below.