Active Ingredients
Lidocaine Hydrochloride(0.5 %)
Australian Gold
FDA Label NDC 58443-0327
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises, Inc. for the product Australian Gold (NDC 58443-0327). 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 ingredients, purpose, indications, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
For external use only
Avoid contact with eyes
if condition worsens, or if 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
Do not use in large quantities, particularly over raw surfaces or bliseterd areas
Keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away.
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:
- Children under 2 years of age:
Apply to afftected area not more than 3 to 4 times daily.
consult a doctor.
Inactive Ingredients
Allantoin, Aloe Barbadensis Leaf Juice, Blue 1, Caprylyl Glycol, Carbomer, Citrus Limon (Lemon) Peel Extract, Glycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Hexylene Glycol, Mentha Viridis (Spearmint) Leaf Oil, Panthenol, PEG-60 Lanolin, Phenoxyethanol, Pollen Extract, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Symphytum Officinale (Comfrey) Leaf Extract, Tilia Cordata Flower Extract, Tocopheryl Acetate, Water
Questions Or Comments?
Call toll free 1-855-LIV-GOLD (546-4653)
Principal Display Panel - 237 Ml Bottle Label
Principal Display Label (58443 0330 4)
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