Label: AUSTRALIAN GOLD ALOE GEL WITH LIDOCAINE- lidocaine hydrochloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0327-4 - Packager: Prime Enterprises, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 12, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Indications
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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.
- Directions
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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
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- PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD ALOE GEL WITH LIDOCAINE
lidocaine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0327 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5.05 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0327-4 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/16/2015 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0327) , pack(58443-0327) , manufacture(58443-0327) , analysis(58443-0327)