LEADER- lidocaine hcl cream

Leader by

Drug Labeling and Warnings

Leader by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Weeks & Leo Company 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

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 and over: apply to affected area not more than 3 to 4 times daily
• children under 2 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

Principal display panel

Leader

NDC: 70000-0098-1

Maximum Strength

Lidocaine

Pain Relief

Cream

Lidocaine HCl 4% Topical Analgesic

Non Greasy

Compare to aspercreme lidocaine cream

active ingredient

100% Money Back Guarantee

Net wt 2.7 oz (76.5g)

INGREDIENTS AND APPEARANCE

LEADER 
lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0098
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 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0098-1	1 in 1 CARTON	10/18/2021
1		76.5 g 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	10/18/2021

Labeler - Cardinal Health (063997360)

Registrant - Weeks & Leo Company Inc (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Company Inc		005290028	manufacture(70000-0098)