ZINC OXIDE - zinc oxide ointment 
CVS

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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drug facts

Active ingredient                      Purpose
Zinc oxide 18%.........................Skin protectant

Uses
- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash and
helps seal out wetness

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

Uses
- helps prevent and treat diaper rash
- protects chafed skin due to diaper rash and
helps seal out wetness


Warnings
For external use only.
_______________________________

When using this product avoid contact with the eyes
_______________________________

Stop use and ask a doctor if condition worsens
or does not improve after seven days

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


Directions
- change wet and soiled diapers immediately
- cleanse the diaper area and allow to dry
- apply ointment liberally and as often as necessary
with each diaper change and especially when
exposed to wet diapers for a prolonged period of
time such as bedtime.
_______________________________

Other information

- Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
- use with infants children and adults
- will stain clothing and fabric

Inactive Ingredients castor oil, citric acid,
mineral oil, paraffin, Peruvian balsam, petrolatum

label


ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-083
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE160 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN (UNII: I9O0E3H2ZE)  
MINERAL OIL (UNII: T5L8T28FGP)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CASTOR OIL (UNII: D5340Y2I9G)  
BALSAM PERU (UNII: 8P5F881OCY)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-083-02113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/19/2009
Labeler - CVS (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 2/2011
Document Id: bcd1940d-100a-4572-be93-6cbb381b5105
Set id: 9e398984-576c-4f5f-bb9a-890f56630cf7
Version: 2
Effective Time: 20110216
 
CVS