NUMBING CREAM- pramoxine hydrochloride 1% cream

Numbing cream by

Drug Labeling and Warnings

Numbing cream 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

Active Ingredient (w/w): Pramoxine Hydrochloride 1% ....External Analgesic

INACTIVE INGREDIENT

Inactive ingredients
Purified Water, Glycerin, Allantoin, Tocopheryl Acetate (Vitamin E), Carbomer, Propylene Glycol, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin

PURPOSE

Purpose ............External analgesic

INDICATIONS & USAGE

Uses

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

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 breast feeding, consult a healthcare provider before use

STOP 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.

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

OTHER SAFETY 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

NUMBING CREAM 
pramoxine hydrochloride 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85284-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
CARBOMER (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85284-008-01	50 g in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/13/2025

Labeler - BLOOMWELL GARDENS LLC (124839891)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd.		724892056	manufacture(85284-008)