ZINC OXIDE by CVS / Pharma Pac, LLC ZINC OXIDE ointment

ZINC OXIDE by

Drug Labeling and Warnings

ZINC OXIDE by is a Otc medication manufactured, distributed, or labeled by CVS, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

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

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-083
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	160 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-083-02	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/19/2009

Labeler - CVS (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture