PREMIER VALUE ZINC OXIDE- zinc oxide ointment

PREMIER VALUE ZINC OXIDE by

Drug Labeling and Warnings

PREMIER VALUE ZINC OXIDE by is a Otc medication manufactured, distributed, or labeled by TAI GUK PHARM. CO., LTD., UNITED EXCHANGE CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                                              Purpose

Zinc oxide, 20% ..............................................................................Skin protectant

PURPOSE

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps protect skin from wetness
• protects and dries the oozing and weeping of poison ivy, poison oak and poison sumac
• helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips
  

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use over deep or puncture wounds, infections or lacerations

WHEN USING

When using this product avoid contact with the eyes

STOP USE

Stop use and ask a doctor if condition worsens or does not improve within 7 days

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

Directions

• change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
• apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  

STORAGE AND HANDLING

Other information

• Lot No. and Exp. Date: see box or see crimp of tube
• store at 20o to 25oC (68o to 77oF)
  

INACTIVE INGREDIENT

Inactive ingredients

White petrolatum, talc, purified lanolin, liquid paraffin, triethanolamine, aloe vera gel, tocopherol acetate, butylated hydroxyloluene, methyl parahydroxybenzoate, purified water

DOSAGE & ADMINISTRATION

Distributed By:

Chain Drug Consortium, LLC.

3301 N.W. Boca Raton Blvd., Suite 101

Boca Raton, FL 33431

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

PREMIER VALUE ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68169-0130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
TALC (UNII: 7SEV7J4R1U)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68169-0130-7	1 in 1 CARTON
1		56 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/08/2010

Labeler - TAI GUK PHARM. CO., LTD. (631101656)

Registrant - UNITED EXCHANGE CORP. (840130579)

Establishment
Name	Address	ID/FEI	Business Operations
TAI GUK PHARM. CO., LTD.		631101656	manufacture