Active Ingredients And Purpose
Active ingredients
Lidocaine Hydrochloride(0.5 %)
Purpose
External Analgesic
Australian Gold Lidocaine ALOE GEL
- Manufacturer
- Prime Enterprises, Inc.
- Effective date
- 2020-05-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:11:03
Key Label Information#
Uses
Indications
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.
Warnings
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 And Dosage
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.
Other Label Information
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
Label Images#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58443-0327-4 | 2023-01-30 | C162847 | 48780-1 | f386c649-e897-0266-e053-dadaa90a7c1a | Australian Gold Lidocaine ALOE GEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58443-0327-4 | Australian GoldAloe Gel with Lidocaine | 237 mL in 1 BOTTLE | GEL | 237 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58443-0327 | AUSTRALIAN GOLD ALOE GEL WITH LIDOCAINE (LIDOCAINE HYDROCHLORIDE) GEL [PRIME ENTERPRISES, INC.] | 1 | Legacy NDC, 1 package rows | 20200513_a575bf5f-e3cd-1ff5-e053-2995a90a5cb3.zip |
Products#
- Australian Gold Aloe Gel with Lidocaine
- Lidocaine Hydrochloride
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58443-0327 | 58443-0327-4 |
Ingredients#
Complete SPL Sections#
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.
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, 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)