BABYS BUTT AID- zinc oxide ointment 
GREENBRIER INTERNATIONAL INC

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.

----------

DRUG FACTS

For external use only

  • flammable, keep away from fire and flame
  • will produce serious gastric disturbances if taken internally

Ask a doctor before use if you have deep puncture wounds or serious burns

When using this product

  • do not get into eyes or mucous membranes
  • use only in a well-ventilated area

Stop use and ask a doctor if condition persists or gets worse.

Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

Active ingredient

Zinc Oxide 16%

Purpose

Skin Protectant

Uses

Warnings

For external use only.

When using this product, avoid contact with 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 any time when exposure to wet diapers may be prolonged.

Other information

store at 20 to 27 C (68 to 80.6 F)

Inactive ingredients

boric acid, castor oil, microcrystalline wax, mineral oil, paraffin, peruvian balsam, petrolatum

Baby Butt Aid LabelEnter section text here

BABYS BUTT AID 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1306
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4) 2 g  in 100 g
CASTOR OIL (UNII: D5340Y2I9G) 30 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP) 31.5 g  in 100 g
PARAFFIN (UNII: I9O0E3H2ZE) 10 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) 10 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-1306-11 in 1 BOX
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2011
Labeler - GREENBRIER INTERNATIONAL INC (610322518)
Registrant - HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED (547695235)
Establishment
NameAddressID/FEIBusiness Operations
HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED547695235manufacture(33992-1306)

Revised: 1/2014
Document Id: c67b9ae5-feb9-461b-b4b9-9474f7ebc28d
Set id: 349d27e8-df53-4d4f-8833-b249e948acee
Version: 2
Effective Time: 20140101
 
GREENBRIER INTERNATIONAL INC