AUSTRALIAN GOLD ALOE GEL WITH LIDOCAINE- lidocaine hydrochloride gel 
Prime Enterprises, Inc.

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.

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Australian Gold Lidocaine ALOE GEL

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 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.

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

    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

AUSTRALIAN GOLD  ALOE GEL WITH LIDOCAINE
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0327
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5.05 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALLANTOIN (UNII: 344S277G0Z)  
SCOTCH SPEARMINT OIL (UNII: I5T0098W81)  
PEG-60 LANOLIN (UNII: K2OI1D27ET)  
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
BEE POLLEN (UNII: 3729L8MA2C)  
COMFREY LEAF (UNII: DG4F8T839X)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
ALPHA-TOCOPHERYLQUINONE (UNII: ZO763K43XR)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 1342 (UNII: 809Y72KV36)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0327-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/16/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/16/2015
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0327) , pack(58443-0327) , manufacture(58443-0327) , analysis(58443-0327)

Revised: 5/2020
Document Id: a575bf5f-e3ce-1ff5-e053-2995a90a5cb3
Set id: a575bf5f-e3cd-1ff5-e053-2995a90a5cb3
Version: 1
Effective Time: 20200512
 
Prime Enterprises, Inc.