C-PATCH GRANDE- 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.

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C-Patch Grande

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 childern

Keep out of reach of children. If swallowed, contact a Poison Control Center or get medical help immediately

C-Patch Grande

c patch grande

C-PATCH GRANDE 
menthol, camphor patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70236-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.7 g  in 28 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.14 g  in 28 g
Inactive Ingredients
Ingredient NameStrength
TARTARIC ACID (UNII: W4888I119H)  
SORBITOL (UNII: 506T60A25R)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
GELATIN (UNII: 2G86QN327L)  
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70236-101-026 in 1 POUCH01/13/2018
1NDC:70236-101-0128 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 finalpart34801/13/2018
Labeler - NeoBiotech Global Corporation (080020820)
Registrant - NeoBiotech Global Corporation (080020820)
Establishment
NameAddressID/FEIBusiness Operations
NeoBiotech Global Corporation080020820manufacture(70236-101)

Revised: 1/2018
Document Id: 62b1ccdf-e788-cee5-e053-2991aa0adc43
Set id: 62b1ccdf-e787-cee5-e053-2991aa0adc43
Version: 3
Effective Time: 20180113
 
NeoBiotech Global Corporation