Otc - Active Ingredient
Arnica Montana 1X HPUS 7%
Gemachlich Zuhause Arthritis Relief Sprays Spray
FDA Label NDC 76986-035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Quadrant Ecological Technology Co., Ltd. for the product Gemachlich Zuhause Arthritis Relief Sprays (NDC 76986-035). 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 - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
TOPICAL PAIN RELIEF
Indications & Usage
Purpose: Promotes local blood circulation, adjunctive therapy for Arthritis, Neuropathy, Tingling,Burning and Numbness. Relieves Muscle Pain, Neuralgia, Stiffness,Swelling, Bruising Symptoms.
Warnings
For external use only.
Otc - Do Not Use
· Do not use if you are allergic to any of the ingredients.
. Do not use if the product has changed in appearance or odor.
.By mouth, in nostrils, on wounds or damaged skin.
.If you are under 18 years of age,consult physician.
Otc - When Using
Avoid contact with eyes.
Otc - Stop Use
Discontinue use and consult a healthcare professional if irritation occurs.
Otc - Keep Out Of Reach Of Children
· Keep away from children and pets immediately after use until the heating sensation subsides.
In case of accidental ingestion, get medical help or contact a poison control center immediately.
Dosage & Administration
Step 1.Point the spray nozzle at the knee joint.
Step 2.Press the nozzle 2 times so that the spray is evenly distributed over the knee joint.
Step 3.Wait until the product is fully absorbed.
Inactive Ingredient
WATER
POLYSORBATE 20
GLYCERIN
METHYLPROPANEDIOL
PANTHENOL
VANILLYL BUTYL ETHER
CENTELLA ASIATICA EXTRACT
AVENA SATIVA (OAT) KERNEL EXTRACT
ROSA RUGOSA FLOWER EXTRACT
LACTOBACILLUS FERMENT
BUTYLENE GLYCOL
GLYCERYL CAPRYLATE
CAPRYLHYDROXAMIC ACID
HYDROXYACETOPHENONE
BUTYLENE GLYCOL
PEG-40 HYDROGENATED CASTOR OIL
ALOE BARBADENSIS LEAF JUICE POWDER
PYRIDOXINE
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
