BOOTY GOO - zinc oxide ointment 
Skin Sake, LLC

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.

----------

Active Ingredient

Drug Facts

Active Ingredient

Zinc Oxide 25%

Purpose

Skin Protectant

Keep out of reach of children

Keep out of reach of children.

Uses

Warnings

For external use only.

When using this product, do not get into eyes.

Stop and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Do not use on deep puncture wounds, animal bites, serious burns.

If swallowed, get medical help or contact a Poison control Center right away.


Directions

Cleanse and dry diaper area. Apply liberally as often as necessary, with each diaper change at least 3 or 4 times a day, definitely at bedtime when wet diapers may be prolonged. Store between 15° - 30° C, (59° - 86° F)

Inactive ingredients

Peruvian Balsam, Vitamin E (Tocopherol), Aloe, Acidum Boricum, White Petrolatum, Mineral Oil, Castor Oil, Microcrystalline Wax, White Beeswax.

Product Label

NDC # 434479440-1

Pharmacist Formulated  Pediatrician Recommended

Booty®Goo

DIAPER CHANGE OINTMENT

Soothes, treats and prevents Diaper Rash

Frangrance Free
Repels Wetness
Natural Ingredients for Healthy Skin
Non-Greasey, Non-Staining

Net Wt 2.5 oz (71g)

VISIBLE IMPROVEMENT WITHIN 24 HRS

Manufactured by:

SKIN SAKE, LLC

P.O. Box 390, Hamburg, AT 71646

1-888-853-5544  bootygoo.com

2101944-03

SS Booty Goo1 Label


BOOTY GOO 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43447-9440
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.75 g  in 71 g
Inactive Ingredients
Ingredient NameStrength
BALSAM PERU (UNII: 8P5F881OCY)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ALOE (UNII: V5VD430YW9)  
BORIC ACID (UNII: R57ZHV85D4)  
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
CASTOR OIL (UNII: D5340Y2I9G)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43447-9440-171 g in 1 TUBE
2NDC:43447-9440-0100 in 1 BOX
2NDC:43447-9440-22 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/01/2005
Labeler - Skin Sake, LLC (195912717)
Registrant - Skin Sake, LLC (195912717)
Establishment
NameAddressID/FEIBusiness Operations
Memphis Contract Packaging, Inc.185390010manufacture(43447-9440)

Revised: 5/2013
Document Id: 332ac550-5435-45b1-83b3-f8d7c0c43792
Set id: e1717250-2847-463a-b0ed-a4434503c1b2
Version: 2
Effective Time: 20130514
 
Skin Sake, LLC