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Pain Relieving by Blaine Labs Inc.

Medically reviewed on April 2, 2018

Dosage form: gel
Ingredients: MENTHOL 3.5mg in 100mL, CAMPHOR (SYNTHETIC) 0.2mg in 100mL
Labeler: Blaine Labs Inc.
NDC Code: 63347-215

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.

Pain Relieving Gel - 215

DRUG FACTS
Active Ingredient

Menthol 3.5%

Camphor 0.2%

Purpose

Topical Analgesic

Keep out of reach of children

Keep  out of reach of children.

If swallowed, get medical help or contact a poison control center immediately.

Indications

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

Warnings

Use only as directed. For external use only. Do not use with other sprays, ointments, creams, or liniments. Do not apply to irritated skin and discontinue use if excessive skin irritation develops. Do not bandage. Do not use with heating pads or devices. When using this product avoid contact with the eyes or mucous membranes. Ask your physician before using on children under two years of age, or if you are pregnant, nursing, or have sensitive skin.

If condition worsen, or if symptoms persist for more than 7 days, or clear up and then recur within a few days, stop use and contact your physician.

Directions

Apply to the affected areas not more than 3-4 times daily.

Rinse hands with cool water.

Other Information

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

Inactive Ingredients

Water, SDA Alcohol 40-B, Carbomer, isopropyl Alcohol, Glycerine, llex Paraguariensis Leaf Extract, Camellia Sinensis (Green Tea) Leaf Powder, Glycerine, Capsaicin, FD&C Blue #1, FD&C Yellow #5, Triethanolamine

Pain Relieving Gel product label

NDC: 63347-215-02

Pain Relieving Gel

PRACTICE
EXCLUSIVE

Menthol 3.5%

Camphor 0.2%

Capsaicin 0.01%

6.0 FL OZ

Manufactured by:
Blaine Labs Inc.

11037 Lockport Place

Santa Fe Springs, CA 90670

PAIN RELIEVING 
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-215
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3.5 mg  in 100 mL
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)0.2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
CARBOMER 934 
ISOPROPYL ALCOHOL 
ILEX PARAGUARIENSIS LEAF 
GREEN TEA LEAF 
GLYCERIN 
CAPSAICIN 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:63347-215-0188.7 mL in 1 TUBE, WITH APPLICATOR
2NDC:63347-215-02177 mL in 1 TUBE
3NDC:63347-215-03946.4 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/2016
Labeler - Blaine Labs Inc. (017314571)
Registrant - Blaine Labs Inc. (017314571)
Establishment
NameAddressID/FEIOperations
Blaine Labs Inc.017314571manufacture(63347-215)

 
Blaine Labs Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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