Otc - Active Ingredient
Arnica montana 1 X HPUS 7%
Walgreens Arnica Aerosol, Spray
FDA Label NDC 0363-3034
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Walgreens Arnica (NDC 0363-3034). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Trauma, muscle pain and stiffness, swelling from injuries, discoloration from bruising
Indications & Usage
Temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and falls
reduces pain, swelling and discoloration from bruises.
Warnings
For external use only
Otc - Do Not Use
Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.
Extremely Flammable
do not use near heat or flame or while smoking
avoid long term storage above 104°F (40°C)
do not puncture or incinerate. Contents under pressure
do not store at temperatures above 120°F (49°C)
Otc - When Using
When using this product
Use only as directed
Avoid spraying on face
Avoid inhalation of spray
Do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
Otc - Ask Doctor
Stop use and ask a doctor if
irritation develops
condition persist for more than 3 days or worsens
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a poison Control Center right away.
Dosage & Administration
Directions:
adults and children over 12 years:
Apply to affected area and massage until thoroughly absorbed into skin.
Repeat 3 times a day or as needed.
Children 12 years or younger: ask a doctor
Inactive Ingredient
Alcohol, Carbomer, phenoxyethanol, sodium hydroxide, tetrafluoroethene, water
Otc - Questions
Questions or comments ? 1-800-925-4733
Package Label.Principal Display Panel
Package Carton (F47001 Proof)
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