OTC Medication Information: C-Patch

C-PATCH- camphor (synthetic) and menthol 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.

Active ingredients

Menthol (2.5%)

Camphor (0.5%)

Purpose

External analgesic

Uses

temporarily relieves symptoms of:

– pain

– itching

– inflammation

– minor irritation

– skin discomfort

– 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 immediately

Directions

Adults and children over 12 years:

– Clean affected skin

– Remove film from patch

– Carefully apply the patch to the affected region and press skin firmly

– Patch can remain on the skin for up to 8 hours

– May repeat as necessary up to a maximum of 3 times per day

– For tick and bee stings, remove tick or stinger before applying patch

Children 12 years and younger: ask a health professional

Inactive ingredients

Charcoal, Gelatin, Aluminum Glycinate, Ethylenediaminetetraacetic acid disodium salt, Eucalyptus oil, Glycerin, Polyvinyl alcohol, Partially neutralized polyacrylate, Pured water, 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

C-Patch

C-PATCH menthol, camphor patch

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70236-100 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 0.045 g in 9 g MENTHOL (MENTHOL) MENTHOL 0.225 g in 9 g

Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS WATER GELATIN, UNSPECIFIED EUCALYPTUS OIL GLYCERIN POLYVINYL ALCOHOL, UNSPECIFIED SODIUM CHLORIDE SORBITOL TARTARIC ACID ACTIVATED CHARCOAL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70236-100-02 5 PATCH in 1 POUCH contains a PATCH (70236-100-01) 1 NDC:70236-100-01 9 g in 1 PATCH This package is contained within the POUCH (70236-100-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/12/2018

Labeler — NeoBiotech Global Corporation (080020820)

Registrant — NeoBiotech Global Corporation (080020820)

Establishment
Name	Address	ID/FEI	Operations
NeoBiotech Global Corporation		080020820	manufacture (70236-100)

Revised: 01/2018 NeoBiotech Global Corporation