PUTRIZEN NUMBING CREAM- glycerin cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

ARNICA MONTANA FLOWER

PURPOSE

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

WHEN USING

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

For external use only.

DO NOT USE

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.

STOP USE

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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!

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PUTRIZEN NUMBING CREAM 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84983-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	0.01 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	1 mg  in 100 mg
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)	0.01 mg  in 100 mg
EMU OIL (UNII: 344821WD61)	0.01 mg  in 100 mg
GLYCERIN (UNII: PDC6A3C0OX)	8 mg  in 100 mg
1,2-HEXANEDIOL (UNII: TR046Y3K1G)	0.1 mg  in 100 mg
MENTHOL (UNII: L7T10EIP3A)	5 mg  in 100 mg
MINERAL OIL (UNII: T5L8T28FGP)	2 mg  in 100 mg
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)	0.1 mg  in 100 mg
AQUA (UNII: 059QF0KO0R)	83.67 mg  in 100 mg
TROLAMINE (UNII: 9O3K93S3TK)	0.1 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84983-027-01	100 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/09/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/09/2026

Labeler - Shantou South Moon Biotechnology Co., Ltd. (457126192)

Establishment
Name	Address	ID/FEI	Business Operations
Shantou South Moon Biotechnology Co., Ltd.		457126192	manufacture(84983-027)