TOPICAL CREAM- lidocaine cream

Topical Cream by

Drug Labeling and Warnings

Topical Cream by is a Otc medication manufactured, distributed, or labeled by BLOOMWELL GARDENS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 4% ---Topical anesthetic

PURPOSE

Local anesthetic

Uses

Temporarily helps reduce discomfort from :

Minor burns, Insect bites,linor skin irritations,Post-shaving or grooming

sensitivity,External itching or rash due to dry skin

Warnings

For external use only

Do not use:

In or near eyes

▪ On large areas of the body or on broken, blistered, or abraded skin

▪ If allergic to local anesthetics such as lidocaine

When using this product:

▪ Avoid contact with eyes

▪ Do not bandage tightly or use with heating pad

▪ Keep out of reach of children

Stop use and ask a doctor if:

▪ Condition worsens or symptoms persist more than 7 days

Redness, rash, or irritation develops

▪ If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children

Directions

▪ Adults and children over 12 years:

▪ Apply a thin layer to affected area not more than 3–4 times daily

▪ Children under 12 years: Consult a doctor before use

▪ Wash hands after application

Inactive ingredients

Purified Water, Glycerin, Allantoin, Tocopheryl Acetate (Vitamin E),

Carbomer, Propylene Glycol, Sodium Hydroxide, Phenoxyethanol,

Ethylhexylglycerin

Other information

Store at room temperature (15–30°C / 59–86°F)

Tamper evident: Do not use if seal is broken or missing

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPICAL CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85284-002
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
CARBOMER (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85284-002-01	50 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/16/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/16/2025

Labeler - BLOOMWELL GARDENS LLC (124839891)