LEADER BURN RELIEF- lidocaine spray

Leader Burn Relief by

Drug Labeling and Warnings

Leader Burn Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Derma Care Research Labs, LLC, Derma Care Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 0.5%

PURPOSE

External Analgesic.

DOSAGE & ADMINISTRATION

For the temporary relief of pain and itching due to sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritations.

WARNINGS

For external use only.

Flammable--do not use while smoking or near heat or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product avoid contact with eyes. Rinse with water to remove. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Shake well before use. Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 2 years of age: ask a doctor. To apply to face, spray in palm of hand and gently apply.

INACTIVE INGREDIENT

Water, Alcohol Denat., Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Disodium Cocoamphodipipropionate, Carbomer, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Propylparaben, methylparaben, Simethicone.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER BURN RELIEF 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0624
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 940 (UNII: 4Q93RCW27E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0624-1	128 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/17/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/17/2023

Labeler - Cardinal Health (063997360)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs		116817470	manufacture(70000-0624)