BOOGIE BOTTOMS- dimethicone and zinc oxide spray

Boogie Bottoms by

Drug Labeling and Warnings

Boogie Bottoms by is a Otc medication manufactured, distributed, or labeled by Nehemiah Manufacturing Company LLC, Trividia Manufacturing Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Zinc Oxide 25%	Skin Protectant
Dimethicone 20%	Skin Protectant

Uses

• Helps treat and prevent diaper rash
• Protects chafed skin due to diaper rash and helps seal out wetness.

Warnings

• For external use only.

• When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

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

• Keep out of reach of children.
• Lock when not in use.
• If swallowed, get medical help or contact a poison control center immediately.

Directions

• Change wet and soiled diapers promptly.
• Cleanse diaper area and allow to dry.
• Shake bottle well before use. Unlock to spray.
• Re-lock when not in use.
• Spray 4-6 inches from skin. No rub-in is required.
• Apply 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 59° F - 87° F

Inactive ingredients

Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, White Petrolatum

Questions?

1.877.469.8877 - MADE IN USA

SPL UNCLASSIFIED SECTION

Distributed by Nehemiah Manufacturing Co,
1907 South St, Cincinnati, OH U.S.A. 45204

PRINCIPAL DISPLAY PANEL - 49 ML Bottle Label

NEW!
NDC: 75957-003-01

Boogie
BOTTOMS™

No-Rub
Diaper Rash Spray
Skin Protectant

SHAKE
WELL

Treats & Prevents diaper rash

Spray-on application

Fast & Easy to use

25% Zinc Oxide

Free from:
fragrances dyes parabens

NET 1.7 FL OZ (49ML)

INGREDIENTS AND APPEARANCE

BOOGIE BOTTOMS 
dimethicone and zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75957-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	200 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
CORN OIL (UNII: 8470G57WFM)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75957-003-01	49 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2018
2	NDC: 75957-003-02	3 in 1 CELLO PACK	06/01/2018
2	NDC: 75957-003-01	49 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 75957-003-03	4 in 1 CELLO PACK	06/01/2018
3	NDC: 75957-003-01	49 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 75957-003-04	1 in 1 BOX	06/01/2018
4	NDC: 75957-003-01	49 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/01/2018

Labeler - Nehemiah Manufacturing Company LLC (831701466)

Establishment
Name	Address	ID/FEI	Business Operations
Trividia Manufacturing Solutions, Inc.		018927392	MANUFACTURE(75957-003) , LABEL(75957-003) , PACK(75957-003)