FDA.reportPublic FDA data

PUTRIZEN Numbing Cream - Shantou South Moon Biotechnology Co., Ltd.

Manufacturer
Shantou South Moon Biotechnology Co., Ltd.
Effective date
2026-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:10

Label at a glance#

ProductPUTRIZEN Numbing Cream
Active ingredientARNICA MONTANA FLOWER
Label structure12 sections

Storage and handling

Store at room temperature 59°F-86°F(159C-309C).Avoid direct sunlight Do not use if tamper-evident packaging has been breached or is missing!

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


ARNICA MONTANA FLOWER

OTC - PURPOSE SECTION

For the temporary relief of localized pain, itching, or discomfort from minor skin irritations.

OTC - WHEN USING SECTION

1.Clean hands and treatment area with mild soap and warm
water, rinse thoroughly,then gently pat dry.
2.Apply a thick layer of numbing cream to the treatment area,
making sure to cover both the treatment area and its
surroundings.
3.wrap tightly with, plastic wrap and wait 40-60 minutes (Longer
time.batter effect)
4.Wipe away residue, and wait another 15-25 minutes for the
numbness to peak.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not get into the eyes.m Do not exceed recommended dosage unless directed by a doctor. m Do not put this product into the rectum by using fingers or any mechanical device or applicator.

OTC - STOP USE SECTION

Do not get into the eyes.m Do not exceed recommended dosage unless directed by a doctor. m Do not
put this product into the rectum by using fingers or any mechanical device or applicator.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

STORAGE AND HANDLING SECTION

Store at room temperature 59°F-86°F(159C-309C).Avoid direct sunlight Do not use if tamper-evident packaging has been breached or is missing!

INACTIVE INGREDIENT SECTION

EUCALYPTUS GLOBULUS LEAF、EMU OIL、AQUA、GLYCERIN、MENTHOL、MINERAL OIL、GLYCERYL MONOSTEARATE、1,2-HEXANEDIOL、CARBOMER HOMOPOLYMER TYPE A、TROLAMINE

DOSAGE & ADMINISTRATION SECTION


1.Clean hands and treatment area with mild soap and warm
water, rinse thoroughly,then gently pat dry.
2.Apply a thick layer of numbing cream to the treatment area,
making sure to cover both the treatment area and its
surroundings.
3.wrap tightly with, plastic wrap and wait 40-60 minutes (Longer
time.batter effect)
4.Wipe away residue, and wait another 15-25 minutes for the
numbness to peak.

INDICATIONS & USAGE SECTION


1.Clean hands and treatment area with mild soap and warm
water, rinse thoroughly,then gently pat dry.
2.Apply a thick layer of numbing cream to the treatment area,
making sure to cover both the treatment area and its
surroundings.
3.wrap tightly with, plastic wrap and wait 40-60 minutes (Longer
time.batter effect)
4.Wipe away residue, and wait another 15-25 minutes for the
numbness to peak.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84983-027-01PUTRIZEN Numbing Cream100 mg in 1 BOTTLE, PLASTICCREAM1001

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84983-02784983-027-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
EMU OIL344821WD61IACT
GLYCERINPDC6A3C0OXIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
MENTHOLL7T10EIP3AIACT
MINERAL OILT5L8T28FGPIACT
CARBOMER HOMOPOLYMER TYPE AF68VH75CJCIACT
AQUA059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT

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
4f0438d8-e9c1-ea1d-e063-6394a90a82514f0438d8-e9c0-ea1d-e063-6394a90a82512026-04-09WarningsExact identifier
spl id: 4f0438d8-e9c1-ea1d-e063-6394a90a8251
spl set id: 4f0438d8-e9c0-ea1d-e063-6394a90a8251

Reported adverse events (FAERS/openFDA)#

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