NUMBING CREAM MAXIMUM STRENGTH- lidocaine cream

numbing cream MAXIMUM STRENGTH by

Drug Labeling and Warnings

numbing cream MAXIMUM STRENGTH by is a Otc medication manufactured, distributed, or labeled by BLOOMWELL GARDENS LLC, Jiangxi Hemei Pharmaceutical Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 4% --- Topical Anesthetic

INACTIVE INGREDIENT

Purified Water, Glycerin, Allantoin, Tocopheryl Acetate

(Vitamin E), Carbomer,Propylene Glycol,

Sodium Hydroxide, Phenoxyetha-nol, Ethylhexylglycerin

PURPOSE

Local anesthetic

INDICATIONS & USAGE

Temporarily helps reduce discomfort from:
Minor burns, insect bites, minor skin
irritations, Post-shaving or grooming sensitivity
External itching or rash due to dry skin

WARNINGS

For external use only
For external use only
Do not use on large areas of the body or on broken,
blistered, or abraded skin.
Avoid contact with eyes,mouth,and mucous membranes.
If pregnant or breastfeeding,consult a healthcare provider
before use

Stop use and ask a doctor if:

Condition worsens or symptoms persist for more than 7 days Skin irritation, rash or allergic reaction occurs.

KEEP OUT OF REACH OF CHILDREN

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

OTHER SAFETY INFORMATION

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

DOSAGE & ADMINISTRATION

▪ 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NUMBING CREAM MAXIMUM STRENGTH 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85284-006
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
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALLANTOIN (UNII: 344S277G0Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85284-006-01	50 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/29/2025

Labeler - BLOOMWELL GARDENS LLC (124839891)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co.,Ltd		724892056	manufacture(85284-006)