Otc - Active Ingredient
Active ingredient:
- Arnica Montana 1X HPUS (7%)
Tagrid Dmso Cream Arnica Montana 1x Hpus (7%) Cream
FDA Label NDC 85384-0020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tagrid Llc for the product Tagrid Dmso Cream Arnica Montana 1x Hpus (7%) (NDC 85384-0020). 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
Purpuse:Topical Analgesic.
"HPUS" indicates that this ingredient is officially monographed in the Homeopathic Pharmacopoeia of the United States
Indications & Usage
Uses:Temporarily relieves minor aches and discomfort associated with muscles and joints..
Warnings
For external use only
Otc - Do Not Use
- Do not use on broken or irritated skin
- Do not bandage tightly or apply heat after use
Otc - When Using
When using this product
- Avoid contact with eyes and mucous membranes
- May cause skin irritation, burning, or redness
- DMSO may carry substances on the skin surface into the body
Otc - Stop Use
Stop use and ask a doctor if
- Condition worsens
- Symptoms persist for more than 7 days
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:
- Cleanse and dry the affected area
- Apply a thin layer over the affected area twice daily (morning and evening)
- Wash hands after each use
- Children under 12 years: ask a doctor
Inactive Ingredient
Inactive ingredients:
- Water (Aqua)
- Dimethyl Sulfoxide (DMSO)
- Aloe Barbadensis Leaf Juice
- Magnesium Chloride
- Methylsulfonylmethane (MSM)
- Arnica Montana Flower Extract
- Glycerin
- Butyrospermum Parkii (Shea) Butter
- Phenoxyethanol
- Ethylhexylglycerin
Other Safety Information
- Store at 20–25°C (68–77°F)
- Protect from excessive heat and direct sunlight
- For external use only
- Store at 20–25°C (68–77°F)
- Protect from excessive heat and direct sunlight
- For external use only
Otc - Questions
Questions or comments?
- [email protected]
- Distributed by TAGRID LLC
- San Francisco, CA, USA 94131
- Website: tagridstore.com
Package Label.Principal Display Panel
Arnica.jpg (Dmos1)
Arnica.jpg (Dmos2)
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