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NDC 70000-0537-01 Leader 10 mg/g Details

Leader 10 mg/g

Leader is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	70000-0537
Product ID	70000-0537_ecb1e0a4-1731-d4cf-e053-2995a90aaf79
Associated GPIs	90850060104004
GCN Sequence Number	016200
GCN Sequence Number Description	lidocaine HCl GEL (GRAM) 1 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	31093
HICL Sequence Number	001478
HICL Sequence Number Description	LIDOCAINE HCL
Brand/Generic	Generic
Proprietary Name	Leader
Proprietary Name Suffix	Burn Relief
Non-Proprietary Name	Lidocaine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	Cardinal Health
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	2024-12-31

Package

Package Images

NDC 70000-0537-01 (70000053701)

Pricing Information	N/A
NDC Package Code	70000-0537-1
Billing NDC	70000053701
Package	226 g in 1 BOTTLE, PLASTIC (70000-0537-1)
Marketing Start Date	2019-12-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 98e61979-6ce4-5033-e053-2995a90a2905 Details

Active ingredient

Lidocaine 1.0% (as Lidocaine HCl)

Purpose

External analgesic

Uses

temporarily relieves pain and itching due to:

minor skin irritations
sunburn
minor burns
scrapes
minor cuts
insect bites

Warnings

For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas

When using this product

• Avoid contact with eyes. If contact occurs, rinse with water to remove.

Stop use and ask a doctor if

condition gets worse
symptoms last more than 7 days
symptoms clear up and occur again in a few days

Keep out of reach of children.

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

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
children under 2 years of age: ask a doctor.

Other information

may stain some fabrics

Inactive ingredients

aloe barbadensis leaf juice, triethanolamine, isoceteth-20, carbomer, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, water, benzophenone-4, blue 1.

Label

INGREDIENTS AND APPEARANCE

LEADER BURN RELIEF

lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0537
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TROLAMINE (UNII: 9O3K93S3TK)
ISOCETETH-20 (UNII: O020065R7Z)
EDETATE SODIUM (UNII: MP1J8420LU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SULISOBENZONE (UNII: 1W6L629B4K)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0537-1	226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/04/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/04/2019

Labeler - Cardinal Health (063997360)

Revised: 11/2022

Document Id: ecb1e0a4-1731-d4cf-e053-2995a90aaf79

Set id: 98e61979-6ce4-5033-e053-2995a90a2905

Version: 2

Effective Time: 20221104