Numbing cream

Manufacturer
BLOOMWELL GARDENS LLC | Jiangxi Hemei Pharmaceutical Co., Ltd.
Effective date
2025-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:21

Label at a glance#

ProductNumbing cream
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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 SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if:
Condition worsens or symptoms persist for more than 7 days
Skin irritation, rash, or allergic reaction occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052684pramoxine HCl 1 % Topical CreamPSN1
1052684pramoxine hydrochloride 10 MG/ML Topical CreamSCD1
1052684pramoxine hydrochloride 1 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85284-008-01Numbing cream50 g in 1 BOTTLECREAM501

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85284-00885284-008-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3c404ff7-8b89-9f6b-e063-6294a90a2d913c404ff7-8b88-9f6b-e063-6294a90a2d912025-08-13WarningsExact identifier
spl id: 3c404ff7-8b89-9f6b-e063-6294a90a2d91
spl set id: 3c404ff7-8b88-9f6b-e063-6294a90a2d91

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.