CAREALL ZINC OXIDE- zinc oxide ointment

CAREALL Zinc Oxide by

Drug Labeling and Warnings

CAREALL Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by New World Imports Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide

PURPOSE

Skin Protectant

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

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

Stop use and ask a doctor if

Condition worsens

Symptoms last more than 7 days or clear up and occur again with a few days

DOSAGE & ADMINISTRATION

Change wet and soiled diapers promptly

Cleanse the diaper area

Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

INACTIVE INGREDIENT

Cetostearyl Alcohol, Cetomacrogol 1000, Light Liquid Paraffin, White Soft Paraffin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Cetostearyl Alcohol (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
Light Mineral Oil (UNII: N6K5787QVP)
Paraffin (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-032-15	425 g in 1 JAR; Type 0: Not a Combination Product	04/04/2013
2	NDC: 51824-032-03	28 g in 1 TUBE; Type 0: Not a Combination Product	04/04/2013
3	NDC: 51824-032-04	56 g in 1 TUBE; Type 0: Not a Combination Product	04/04/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/04/2013

Labeler - New World Imports Inc (075372276)