LEADER LIDOCAINE- lidocaine hcl liquid

Leader Lidocaine by

Drug Labeling and Warnings

Leader Lidocaine by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCl 4%

Purpose

Topical analgesic

Uses

temporarily relieves pain and itching due to:

• minor burns
• sunburn
• minor cuts
• scrapes
• insect bites
• minor skin irritations

Warnings

For external use only

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

When using this product do not get into eyes

Stop use and ask a doctor if

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

Flammable Keep away from fire or flame

If pregnant or breast-feeding, ask a health professional before use

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

Directions

• adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
• children under 12 years: ask a doctor

Other information

store between 20 °C and 25 °C (68 °F and 77 °F)

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,
C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

Questions or comments?

call 515-276-1586

Principal display panel

Leader

NDC: 70000-0099-1

Maximum Strength

Lidocaine

Pain Relief

Liquid

Lidocaine HCl, 4% Topical Analgesic

No Mess

Applicator

Compare to

Aspercreme

Lidocaine liquid

active ingredient

100% Money Back Guarantee

2.5 Fl oz (73 mL)

INGREDIENTS AND APPEARANCE

LEADER LIDOCAINE 
lidocaine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0099
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
STEARETH-21 (UNII: 53J3F32P58)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0099-1	1 in 1 CARTON	10/20/2021
1		73 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/20/2021

Labeler - CARDINAL HEALTH (063997360)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(70000-0099)