BABYS BUTT AID- zinc oxide ointment

BABYS BUTT AID by

Drug Labeling and Warnings

BABYS BUTT AID by is a Otc medication manufactured, distributed, or labeled by GREENBRIER INTERNATIONAL INC, HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

WARNINGS

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

BABYS BUTT AID 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-1306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	16 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-1306-1	1 in 1 BOX
1		56 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2011

Labeler - GREENBRIER INTERNATIONAL INC (610322518)

Registrant - HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED (547695235)

Establishment
Name	Address	ID/FEI	Business Operations
HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED		547695235	manufacture(33992-1306)