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NDC 46122-0654-34 Burn Relief Aloe Vera Gel 0.5 g/100mL Details

Burn Relief Aloe Vera Gel 0.5 g/100mL

Burn Relief Aloe Vera Gel is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Amerisource Bergen. The primary component is LIDOCAINE.

Product Information

NDC	46122-0654
Product ID	46122-654_d5cab181-c104-c95c-e053-2995a90a0708
Associated GPIs	90850060104003
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Burn Relief Aloe Vera Gel
Proprietary Name Suffix	GNP
Non-Proprietary Name	Lidocaine Hl
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.5
Active Ingredient Units	g/100mL
Substance Name	LIDOCAINE
Labeler Name	Amerisource Bergen
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 46122-0654-34 (46122065434)

Pricing Information	N/A
NDC Package Code	46122-654-34
Billing NDC	46122065434
Package	237 mL in 1 CONTAINER (46122-654-34)
Marketing Start Date	2021-01-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a98a9a80-227c-45bf-8004-44575006db2f Details

Active ingredients Purpose

Lidocaine Hydrochloride 0.5% ............. External Analgesic

SPL UNCLASSIFIED SECTION

Uses

For the temporary relief of pain and itching due to • sunburn • minor burns • insect bites • minor cuts • scrapes • minor skin irritation

Warnings For external use only.

When using this product: • avoid contact with eyes. Rinse with water if contact occurs.

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

Stop use and ask doctor if • symptoms persist for more than 7 days, or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 2 years and older: apply to affected area not more than 3 - 4 times a day.

• Children under 2 years of age: consult a physician.

Inactive ingredients

Aloe Barbadensis Leaf Extract, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, lsopropyl Alcohol, Menthol, Polysorbate 80, Propylene Glycol, Triethanolamine, Water, Yellow 5.

Questions or comments?

888-793-8450

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN RELIEF ALOE VERA GEL GNP

lidocaine hl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-654
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
CARBOMER 940 (UNII: 4Q93RCW27E)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MENTHOL (UNII: L7T10EIP3A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46122-654-34	237 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/15/2021

Labeler - Amerisource Bergen (007914906)

Registrant - Inspec Solutions LLC (081030372)

Name	Address	ID/FEI	Business Operations
Establishment
Inspec Solutions LLC		081030372	manufacture(46122-654)

Revised: 1/2022

Document Id: d5cab181-c104-c95c-e053-2995a90a0708

Set id: a98a9a80-227c-45bf-8004-44575006db2f

Version: 3

Effective Time: 20220117