Search by Drug Name or NDC

NDC 69103-5100-00 Lidocaine Hydrochloride 18 g/L Details

Lidocaine Hydrochloride 18 g/L

Lidocaine Hydrochloride is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Provision Medical. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	69103-5100
Product ID	69103-5100_804ba9d5-dab0-4491-b744-5a2b207383ed
Associated GPIs
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	Lidocaine Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	18
Active Ingredient Units	g/L
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	Provision Medical
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 69103-5100-00 (69103510000)

Pricing Information	N/A
NDC Package Code	69103-5100-0
Billing NDC	69103510000
Package	.118 L in 1 BOTTLE (69103-5100-0)
Marketing Start Date	2022-07-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c2b84d0e-1a6c-4468-bd40-b14f30f28b79 Details

Active ingredients

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief for minor burns

Warnings

For external use only

Do not use

in large quantities, particularly over raw or blistered areas
near eyes, if this happens rinse thoroughly with water

Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns

Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away

Directions

for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
for children under 2 years of age consult a physician

Inactive ingredients

aloe vera, germaben II, propylene glycol, purified water

Principal Display Panel – 2 fl. oz Bottle Label

The Provision

First Aid

Line™

First Aid

Burn Spray

For Temporary

Pain Relief of

Minor Burns

2 fl. oz. (59.1 ml)

Reorder no. 3500

Principal Display Panel – 2 fl. oz Bottle Label

INGREDIENTS AND APPEARANCE

LIDOCAINE HYDROCHLORIDE

lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69103-5100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	18 g in 1 L

Ingredient Name	Strength
Inactive Ingredients
aloe vera leaf (UNII: ZY81Z83H0X)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
methylparaben (UNII: A2I8C7HI9T)
diazolidinyl urea (UNII: H5RIZ3MPW4)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69103-5100-0	0.118 L in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/25/2022

Labeler - Provision Medical (036936831)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(69103-5100)

Revised: 11/2013

Document Id: 804ba9d5-dab0-4491-b744-5a2b207383ed

Set id: c2b84d0e-1a6c-4468-bd40-b14f30f28b79

Version: 1

Effective Time: 20131111