LIDOCAINE 3%- lidocaine hcl 3% cream

Lidocaine 3% by

Drug Labeling and Warnings

Lidocaine 3% by is a Otc medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine HCl 3%

Purpose

Topical Analgesic

Uses

For the temporarily relief of pain and itching associated with:
minor burns sunburn minor cuts scrapes insect bites minor skin irritations rashes due to poison ivy, poison oak, or poison sumac.

Warnings

For External Use Only

When using this product:

Avoid contact with the eyes. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a licensed healthcare practitioner.

Keep this and all other drugs out of the reach of children.

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: do not use, consult a licensed healthcare practitioner.

Other information

Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]

Inactive ingredients:

Aqua (Purified Water), Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Sodium Phosphate.

Lidocaine 3% Cream

INGREDIENTS AND APPEARANCE

LIDOCAINE 3% 
lidocaine hcl 3% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM PHOSPHATE (UNII: SE337SVY37)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
CALCIUM ACETATE (UNII: Y882YXF34X)
CETEARETH-20 (UNII: YRC528SWUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-241-07	85 g in 1 TUBE; Type 0: Not a Combination Product	08/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/12/2025

Labeler - PureTek Corporation (785961046)