LIDOCAINE CREAM, 4%- lidocaine cream

Lidocaine Cream, 4% by

Drug Labeling and Warnings

Lidocaine Cream, 4% by is a Otc medication manufactured, distributed, or labeled by IPG PHARMACEUTICALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4%

Purposes

Topical Analgesic

Uses

For the temporary relief of pain and itching, associated with minor burns,sun burn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, fever blister, cold sores.

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 doctor.

Warning

Warnings for External Use only

• Avoid contact with eyes
• Do not use in large quantities, particularly over raw surface or blistered area

Stop Use and Ask a Doctor if

• condition worsens 
• or if symptoms persist for more than 7 days
• or 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.

KEEP OUT OF REACH OF CHILDREN

Other Information 

• Store at room temperature, 20 – 25°C (68-77°F).

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorabte-20, Polysorbate-60, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Triethanolamine.

Product label

INGREDIENTS AND APPEARANCE

LIDOCAINE CREAM, 4% 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71085-075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCOL STEARATE (UNII: 0324G66D0E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
JOJOBA OIL (UNII: 724GKU717M)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71085-075-60	60 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	01/13/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/13/2025

Labeler - IPG PHARMACEUTICALS, INC. (080441238)