Otc - Active Ingredient
Active Ingredient:
ARNICA MONTANA 1X
Arniflora Gel
FDA Label NDC 53499-5090
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc for the product Arniflora (NDC 53499-5090). 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, inactive ingredient, dosage & administration, indications & usage, otc - purpose, warnings, otc - keep out of reach of children, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients:
CARBOMER HOMOPOLYMER TYPE C
ETHYL ALCOHOL
PURIFIED WATER
SODIUM HYDROXIDE
WITCH HAZEL DISTILLATE
Dosage & Administration
Dosage and Administration:
Boericke and Tafel Brand:
Directions:
Apply thin layer to affected area
Massage gently or use compress.
For best results, use promptly after injury or trauma occurs
Adults and Children 2 years of age and older: apply to affected area up to 4 times daily
Children under 2: Consult a doctor.
Patch test recommened on sensitive skin
Indications & Usage
Indications and Usage:
Temporarily relievews muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.
Reduces pain, swelling, and discoloration from bruises
Otc - Purpose
Purpose:
Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.
Reduces pain, swelling, and discoloration from bruises
Warnings
Warnings:
For external use only.
Avoid contact with eyes or broken skin.
Do not use if hypersensitive to any ingredients in this product.
Otc - Keep Out Of Reach Of Children
Keep out of Reach of Children:
Keep out of reach of children.
Otc - Ask Doctor
Ask the Doctor:
If skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days or if symptoms clear up and occur againin within a few days.
This could be signs for a serious condition.
Otc - Pregnancy Or Breast Feeding
OTC - Pregnancy or Breast Feeding
Breast-feeding women should not apply to breast area.
Overdosage
Overdose
If swallowed, seek medical help or contact a Poison Control Center immediately.
Package Label.Principal Display Panel:Boericke And Tafel Arniflora Gel21825090 28 Gm 21825097 78 Gm
ARNIFLORA_21825090_05
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