LIDOCAINE HYDROCHLORIDE liquid

Lidocaine Hydrochloride by

Drug Labeling and Warnings

Lidocaine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Use

Temporarily relieves pain associated with minor burns.

Warnings

For external use only.

Do not use

• in eyes, if contact occurs rinse thoroughly with water
• in large quantities, particularly over raw or blistered areas

Stop use and ask a doctor if condition worsens, or persists for more than 7 days or clears up and returns

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

Directions

• adults and children 2 years of age and older: spray an even layer of burn spray over affected area not more than 3-4 times daily
• children under 2 years of age: consult a doctor

Inactive ingredients

aloe vera, diazolidinyl urea, propylene glycol, purified water
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QUESTIONS

Questions? 1.800.835.2263

PRINCIPAL DISPLAY PANEL

Bottle Label

INGREDIENTS AND APPEARANCE

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0934(NDC:61010-5100)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0934-01	59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/16/2023
2	NDC: 0924-0934-02	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/16/2023

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-0934) , repack(0924-0934)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-0934) , repack(0924-0934)