Active Ingredients
Camphor (0.5%)
Menthol (2.5%)
Dental C-patch
FDA Label NDC 70236-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neobiotech Global Corporation for the product Dental C-patch (NDC 70236-104). 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 active ingredients, purpose, uses, warnings, directions, inactive ingredients, keep out of reach of children, dental c-patch, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Uses
temporarily relieves symptoms of
- discomfort after dental procedure
- inflammation
- minor irritation
- swelling
Warnings
For external use only
When using this product
Use only as directed.
- Do not bandage tightly or use with heating pad
- Avoid contact with eyes and mucus membranes
- Do not appy wounds or broken skin
- Do not apply to large areas of the body
- In case of deep or puncture wounds, animal bites or serious burns, consult a doctor
Stop use and ask a doctor if
- condition worsen
- irritation develops
- symptoms persist for more than 7 days or recurs within 1 day of discontinuation
- do not use for more than 7 days
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children. If swallowd, contact a Poison Control Center or get medical help immediatel
Directions
Adults and children over 12 years:
- remove film from patch
- carefully apply the patch to the affected skin over the area of ental procedure
- press patch onto skin firmly
- patch can remain on the skin for up to 8 hours
- may repeat as necessary up to 3 times per day
Inactive Ingredients
Charcoal, gelatin, Aluminum glycinate, Ethylenediaminetetraacetic acid, disodium slat, eucalyptus oil, glycerin, polyvlnyl alcohol, partially neutralized polyacrytate, pured wter, salt, sorbitol, tartaric acid
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, contact a Poison Control Center or get medical help immediately
Dental C-Patch
Dental C-patch (Dental)
* Please review the disclaimer below.
