PUTRIZEN ARNICA BRUISE CREAM- glycerin cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

MENTHA SUAVEOLENS LEAF、PANTHENOL、ARNICA MONTANA FLOWER、COCONUT OIL、MENAQUINONE 7、ASCORBIC ACID、TOCOPHEROL

PURPOSE

For the temporary relief of pain, swelling, and discoloration due to ·minor bruising · muscle overexertion·or skin discomfort.

WHEN USING

1.Clean and dry the bruise area.
2.Apply a small amount of cream directly onto the bruise or affected area.
3.Gently massage in upward circular motions until fully absorbed.
4.Pay special attention to fragile or delicate skin areas.
5.Use 2-3 times daily or as needed.

WARNINGS

For external use only.
Do not use if you are allergic to Amnica Montana or any of the ingredients.
Avoid contact with eyes, mucous membranes, or broken skin.
Stop use and ask a doctor if condition worsens or symptoms persist for more
than 3 days.
Keep out of reach of children. In case of ingestion, seek medical help or contact
a Poison Control Center immediately.

DO NOT USE

Do not use if you are allergic to Amnica Montana or any of the ingredients.

STOP USE

Stop use and ask a doctor if condition worsens or symptoms persist for more
than 3 days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

STORAGE AND HANDLING

Store in a cool and dry place.

INACTIVE INGREDIENT

WATER、GLYCERIN、MINERAL OIL、GLYCERYL MONOSTEARATE、1,2-HEXANEDIOL、CARBOMER HOMOPOLYMER TYPE A 、TROLAMINE、ALLANTOIN

DOSAGE & ADMINISTRATION

1.Clean and dry the bruise area.
2.Apply a small amount of cream directly onto the bruise or affected area.
3.Gently massage in upward circular motions until fully absorbed.
4.Pay special attention to fragile or delicate skin areas.
5.Use 2-3 times daily or as needed.

INDICATIONS & USAGE

1.Clean and dry the bruise area.
2.Apply a small amount of cream directly onto the bruise or affected area.
3.Gently massage in upward circular motions until fully absorbed.
4.Pay special attention to fragile or delicate skin areas.
5.Use 2-3 times daily or as needed.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PUTRIZEN ARNICA BRUISE CREAM 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84983-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8)	TOCOPHEROL	0.12 mg  in 120 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	0.12 mg  in 120 mg
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.12 mg  in 120 mg
MENAQUINONE 7 (UNII: 8427BML8NY) (MENAQUINONE 7 - UNII:8427BML8NY)	MENAQUINONE 7	0.12 mg  in 120 mg
MENTHA SUAVEOLENS LEAF (UNII: 1341ZC68MK) (MENTHA SUAVEOLENS LEAF - UNII:1341ZC68MK)	MENTHA SUAVEOLENS LEAF	1.08 mg  in 120 mg
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	0.12 mg  in 120 mg
COCONUT OIL (UNII: Q9L0O73W7L) (COCONUT OIL - UNII:Q9L0O73W7L)	COCONUT OIL	0.12 mg  in 120 mg

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)	0.12 mg  in 120 mg
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)	0.24 mg  in 120 mg
1,2-HEXANEDIOL (UNII: TR046Y3K1G)	0.6 mg  in 120 mg
WATER (UNII: 059QF0KO0R)	101.4 mg  in 120 mg
TROLAMINE (UNII: 9O3K93S3TK)	0.24 mg  in 120 mg
GLYCERIN (UNII: PDC6A3C0OX)	9.6 mg  in 120 mg
MINERAL OIL (UNII: T5L8T28FGP)	3.6 mg  in 120 mg
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	2.4 mg  in 120 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84983-026-01	120 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(84983-026)