DENTAL C-PATCH- menthol, camphor patch

Dental C-Patch by

Drug Labeling and Warnings

Dental C-Patch by is a Otc medication manufactured, distributed, or labeled by NeoBiotech Global Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DENTAL C-PATCH 
menthol, camphor patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70236-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.07 g  in 14 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.35 g  in 14 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70236-104-02	5 in 1 POUCH	02/10/2018
1	NDC: 70236-104-01	14 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/10/2018

Labeler - NeoBiotech Global Corporation (080020820)

Registrant - NeoBiotech Global Corporation (080020820)

Establishment
Name	Address	ID/FEI	Business Operations
NeoBiotech Global Corporation		080020820	manufacture(70236-104)