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Australian Gold Aloe Freeze Gel with Lidocaine

Medically reviewed on Jan 1, 2018

Dosage form: gel
Ingredients: LIDOCAINE 4.10mg in 1mL
Labeler: Prime Enterprises, Inc.
NDC Code: 58443-0137

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

For external use only.

Avoid contact with eyes.

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.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

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)

AUSTRALIAN GOLD  ALOE FREEZE GEL WITH LIDOCAINE
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0137
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE4.10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
FD&C BLUE NO. 1 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
POLYSORBATE 20 
PROPYLENE GLYCOL 
TROLAMINE 
WATER 
CAPRYLYL GLYCOL 
PHENOXYETHANOL 
HEXYLENE GLYCOL 
PANTHENOL 
ALLANTOIN 
SCOTCH SPEARMINT OIL 
PEG-60 LANOLIN 
CITRUS BIOFLAVONOIDS 
BEE POLLEN 
COMFREY LEAF 
TILIA CORDATA FLOWER 
ALPHA-TOCOPHERYLQUINONE 
GLYCERIN 
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58443-0137-4237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/09/2014
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIOperations
Prime Enterprises, Inc.101946028label(58443-0137), pack(58443-0137), manufacture(58443-0137), analysis(58443-0137)

 
Prime Enterprises, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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