WESTERN FAMILY DIAPER RASH- zinc oxide ointment

WESTERN FAMILY DIAPER RASH by

Drug Labeling and Warnings

WESTERN FAMILY DIAPER RASH 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, 40% ........................................................................Skin protectant

PURPOSE

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps protect skin from wetness
• helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips
  

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

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

INACTIVE INGREDIENT

Inactive ingredients

BHA, cod liver oil (high in vitamins A and D), fragrance, lanolin, light mineral oil, methylparaben, petrolatum, purified water, talc, tartrazine yellow #4 (FD and C yellow #4)

DOSAGE & ADMINISTRATION

Proudly Distributed By:

Western Family Foods, Inc.

P.O. Box 4057, Portland, OR 97208 U.S.A.

Copyright 2010 Marca Registrada

www.westernfamily.com

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

WESTERN FAMILY DIAPER RASH 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68169-0375
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.40 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COD LIVER OIL (UNII: BBL281NWFG)
LANOLIN (UNII: 7EV65EAW6H)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68169-0375-4	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	10/05/2010

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