DENTAL C-PATCH- menthol, camphor patch 
NeoBiotech Global Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Dental C-Patch

Active ingredients

Camphor (0.5%)

Menthol (2.5%)

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 C-PATCH 
menthol, camphor patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70236-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.07 g  in 14 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.35 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
EDETIC ACID (UNII: 9G34HU7RV0)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
SORBITOL (UNII: 506T60A25R)  
TARTARIC ACID (UNII: W4888I119H)  
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70236-104-025 in 1 POUCH02/10/2018
1NDC:70236-104-0114 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/10/2018
Labeler - NeoBiotech Global Corporation (080020820)
Registrant - NeoBiotech Global Corporation (080020820)
Establishment
NameAddressID/FEIBusiness Operations
NeoBiotech Global Corporation080020820manufacture(70236-104)

Revised: 2/2018
Document Id: 64dd06d5-da2f-3a74-e053-2a91aa0a6d3b
Set id: 64dd06d5-da2e-3a74-e053-2a91aa0a6d3b
Version: 2
Effective Time: 20180210
 
NeoBiotech Global Corporation