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Name:Being Well Diaper Rash Creamy
Manufacturer:Tai Guk Pharm. Co., Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BEING WELL DIAPER RASH CREAMY  - zinc oxide ointment 
TAI GUK PHARM. CO., LTD.

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 10% ........................................................................ Skin protectant         

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 over deep or puncture wounds, infections or lacerations

When using this product avoid contact with the eyes

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

Other information

  • store at room temperature
  • Lot No and Exp. Date: see box or see crimp of tube

Inactive ingredients

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

Distributed by: Preferred Products, Inc.

                      Earth City, MO 63045


Product of Korea


image of carton labelEnter section text here


BEING WELL DIAPER RASH CREAMY 
zinc oxide ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68169-3229
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.10 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
TALC  
LANOLIN  
MINERAL OIL  
TROLAMINE  
ALOE VERA LEAF  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68169-3229-5 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 57 g in 1 TUBE This package is contained within the CARTON (68169-3229-5)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 11/17/2010

Labeler - TAI GUK PHARM. CO., LTD. (631101656)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
Name Address ID/FEI Operations
TAI GUK PHARM. CO., LTD. 631101656 manufacture

Revised: 11/2010 TAI GUK PHARM. CO., LTD.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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