CAREALL Zinc Oxide by New World Imports Inc Drug Facts

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]

CAREALL ZINC OXIDE- zinc oxide ointment 
New World Imports Inc

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.

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Drug Facts

Zinc Oxide

Skin Protectant

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

Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash and helps seal out wetness

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

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

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

CAREALL ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-008
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: 51824-008-01	28 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2012	01/01/2020
2	NDC: 51824-008-02	56 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2012	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2012	01/01/2020

Labeler - New World Imports Inc (075372276)

Revised: 10/2019

Document Id: 0f517d92-15d5-4017-ad4c-630853ad2486

34390-5

Set id: 0614f14a-bb55-48bd-9c54-2702b4cd4041

Version: 6

Effective Time: 20191002