ORTHO-NESIC WITH CAPSAICIN- menthol gel

Ortho-Nesic With Capsaicin by

Drug Labeling and Warnings

Ortho-Nesic With Capsaicin by is a Otc medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Capsaicin Label

DISPENSED BY PHYSICIANS
NDC: 63347-401-02

BLAINE LABS

ORTHO-NESIC®

PAIN-REVIEVING GEL

MENTHOL AND CAMPHOR
GEL CONTAINING CAPSAICIN

946.4 mL (32.0 FL OZ)

MANUFACTURED BY:

BLAINE LABS, INC.

11037 LOCKPORT PLACE

SANTE FE SPRINGS, CA 90670

QUESTIONS OR COMMENTS?

CALL (800) 307-8818, M-F, 8:00AM - 5:00PM (PST)

* MADE IN THE U.S.A.

15100-P-LBL32 REV20150908

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INGREDIENTS AND APPEARANCE

ORTHO-NESIC WITH CAPSAICIN 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CARBOMER 934 (UNII: Z135WT9208)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPSAICIN (UNII: S07O44R1ZM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-401-01	170 g in 1 TUBE; Type 0: Not a Combination Product	01/01/1995
2	NDC: 63347-401-02	907 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/1995
3	NDC: 63347-401-03	3629 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/1995
4	NDC: 63347-401-04	85 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	01/01/1995

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/1995

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-401)