ORTHO-NESIC WITH CAPSAICIN - menthol gel 
Blaine Labs Inc.

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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Active Ingredients

Camphor - 0.2%

Menthol - 3/5%

Inactive Ingredients

Water, SDA Alcohol 40-B, Carbomer, Isopropyl Alcohol, Ilex Paraguariensis Leaf Extract, Camelia Sinensis (Green Tea) Leaf Powder, FD and C Blue #1, FD and C Yellow #5, Triethanolamine

Purpose

Topical Analgesic

Uses

For temporary relief from minor aches and pains of sore muscles and joints associated with arthritis pain, backache, strains and sprains

Directions: Apply to the affected areas not more than 3 to 4 times daily.  Rinse hands with cool water.

Ask Your Physician

Ask Your Physician

Before use if you are pregnant, nursing or have sensitive skin

Before use on children under the age of 2 years old

Keep Out Of The Reach Of Children

Stop Use and Contact Your Physician if conditions worsen or if symptoms persist for more than 7 days, or clear up and recur again within a few days.

When Using This Product

Avoid contact with the eyes or mucous membranes.  In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Other Information

Store in a cool dry place with lid closed tightly.  Keep away from excessive heat or open flame

Warnings

Use only as directed.  For external use only.  Do not use with other sprays or ointments creams or liniments.  Do not apply to irritated skin or if excessive irritation develops.  Do Not bandage.  Do not sue with heating pads or devices.

Ortho-Nesic Label

Ortho-Nesic Pain Relieving Gel  Penetrates Fast and Deep  Relieves Sore Muscles and Joints

Physician Formula  Greaseless, Stainless  Great for Arthritis and Sports Injuries  Stops the Pain.  With Capsaicin, Ilex and Green Tea. Paraben Free

3 Ounce Tube Label

6 Ounce Tube Label

1 Gallon Label





ORTHO-NESIC WITH CAPSAICIN 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65373-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
CARBOMER 934 (UNII: Z135WT9208)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TROLAMINE (UNII: 9O3K93S3TK)  
CAPSAICIN (UNII: S07O44R1ZM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65373-401-01170 g in 1 TUBE
2NDC:65373-401-02907 g in 1 BOTTLE, PUMP
3NDC:65373-401-033629 g in 1 BOTTLE, PUMP
4NDC:65373-401-0485 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/1995
Labeler - Blaine Labs Inc. (017314571)
Registrant - Blaine Labs Inc. (017314571)
Establishment
NameAddressID/FEIBusiness Operations
Blaine Labs Inc.017314571manufacture

Revised: 1/2011
Document Id: 37672821-f011-4436-be93-a9c8832e26bf
Set id: b000b58f-a407-411e-8d35-8459fe1b9297
Version: 2
Effective Time: 20110125
 
Blaine Labs Inc.