BOOTY GOO- zinc oxide ointment

Booty Goo by

Drug Labeling and Warnings

Booty Goo by is a Otc medication manufactured, distributed, or labeled by Skin Sake, LLC, Memphis Contract Packaging, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Helps soothe, treat , and prevent diaper rash
• Repels wetness
• Protects delicate skin
• Relieves chapped, moist or irritated areas
• Prevents Friction
  

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

INGREDIENTS AND APPEARANCE

BOOTY GOO 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43447-9440
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.75 g  in 71 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43447-9440-1	71 g in 1 TUBE
2	NDC: 43447-9440-0	100 in 1 BOX
2	NDC: 43447-9440-2	2 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	12/01/2005

Labeler - Skin Sake, LLC (195912717)

Registrant - Skin Sake, LLC (195912717)

Establishment
Name	Address	ID/FEI	Business Operations
Memphis Contract Packaging, Inc.		185390010	manufacture(43447-9440)