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Zepol Topical Analgesic

Dosage form: ointment
Ingredients: CAMPHOR (SYNTHETIC) 6.55g in 100g, MENTHOL 6.55g in 100g
Labeler: Laboratorios Zepol S.A.
NDC Code: 55715-001

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.

Ointment Zepol Topical Analgesic

Active Ingredients      
Camphor 6.55%
Menthol 6.55%

PurposeTopical Analgesic

UsesFor the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, strains, bruises and sprains.

WarningsFor external use only.
Avoid contact with eyes.

Warnings (Continued)
Do not apply to wounds or damaged
skin.
Do not bandage tightly.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

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

Directions:-Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4  times daily. -Children under 2 years of age: Consult a physician.

Other information

Store at 30 degrees C (86 degrees F).

Inactive Ingredients

Eucalyptol, Petrolatum, Thyme Oil, Turpentine Oil Rectified.

Enter section text here

ZEPOL TOPICAL ANALGESIC 
camphor, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55715-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)6.55 g  in 100 g
MENTHOL (MENTHOL) MENTHOL6.55 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EUCALYPTOL 
PETROLATUM 
TURPENTINE 
THYME OIL 
Packaging
#Item CodePackage Description
1NDC:55715-001-0130 g in 1 TUBE
2NDC:55715-001-901 TUBE (TUBE) in 1 BOX
290 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/05/2009
Labeler - Laboratorios Zepol S.A. (853070985)

Revised: 03/2011
Document Id: d474be62-1402-4a45-b3c6-a80ab641f556
Set id: ca20ade6-9b35-40bb-b3b2-fc3a0e1eece9
Version: 2
Effective Time: 20110310
 
Laboratorios Zepol S.A.

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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