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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%

Purpose

Topical Analgesic

Uses

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

Warnings

For 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 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)

Document Id: 6155ed6e-f91c-8a9d-e053-2a91aa0a2bd6
Set id: ca20ade6-9b35-40bb-b3b2-fc3a0e1eece9
Version: 3
Effective Time: 20171227
 
Laboratorios Zepol S.A.

Medically reviewed on Dec 27, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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