LEADER AFTER SUN COOLING- lidocaine hydrochloride gel

Leader by

Drug Labeling and Warnings

Leader by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine hydrochloride 0.5%

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

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

WHEN USING

When using this product

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

ASK DOCTOR

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

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 SAFETY INFORMATION

Other information may stain some fabrics

Inactive Ingredients

aloe barbadensis leaf juice, water, isopropyl alcohol, propylene glycol, glycerin, triethanolamine, carbomer, polysorbate 80, diazolidinyl urea, menthol, disodium EDTA, yellow 5, blue 1

Questions or comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

Leader After Sun Cooling Gel

NET WT 8 OZ (226 g)

NDC: 70000-0534-1

INGREDIENTS AND APPEARANCE

LEADER  AFTER SUN COOLING
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0534
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
WATER (UNII: 059QF0KO0R)
MENTHOL (UNII: L7T10EIP3A)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0534-1	226 g in 1 BOTTLE; Type 0: Not a Combination Product	11/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/04/2019

Labeler - CARDINAL HEALTH, INC. (097537435)

Registrant - FRUIT OF THE EARTH, INC. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(70000-0534)