Otc - Active Ingredient
MENTHA SUAVEOLENS LEAF、PANTHENOL、ARNICA MONTANA FLOWER、COCONUT OIL、MENAQUINONE 7、ASCORBIC ACID、TOCOPHEROL
Putrizen Arnica Bruise Cream
FDA Label NDC 84983-026
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shantou South Moon Biotechnology Co., Ltd. for the product Putrizen Arnica Bruise Cream (NDC 84983-026). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - when using, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
For the temporary relief of pain, swelling, and discoloration due to ·minor bruising · muscle overexertion·or skin discomfort.
Otc - 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.
Otc - Do Not Use
Do not use if you are allergic to Amnica Montana or any of the ingredients.
Otc - Stop Use
Stop use and ask a doctor if condition worsens or symptoms persist for more
than 3 days.
Otc - 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.
Package Label.Principal Display Panel
Label (Ndc 1)
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