ANCALIMA ZINC OXIDE- zinc oxide ointment

Ancalima Zinc Oxide by

Drug Labeling and Warnings

Ancalima Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by ANCALIMA LIFESCIENCES LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 20% w/w

Purpose

Diaper Rash Cream

Uses

■ helps treat and prevent diaper rash ■ dries the oozing and weeping of ■ poison ivy ■ poison oak ■ poison sumac

Warnings

For external use only

When using this product

■ do not get into eyes

■ do not use over large areas of the body

Stop use and ask a doctor if

■ the condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days ■ if you are allergic to any of these ingredients

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

Directions

■ for diaper rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak sumac ■ apply ointment liberally as often as needed

Other Information

■ store at 59-86F (15-30C)

Inactive Ingredients

cetostearyl alcohol, cetomacrogol 1000, light liquid paraffin, white soft parrafin

Package Label

INGREDIENTS AND APPEARANCE

ANCALIMA ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73014-3040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73014-3040-3	28 g in 1 TUBE; Type 0: Not a Combination Product	04/08/2019
2	NDC: 73014-3040-4	56 g in 1 TUBE; Type 0: Not a Combination Product	04/08/2019
3	NDC: 73014-3040-5	425 g in 1 JAR; Type 0: Not a Combination Product	04/08/2019
4	NDC: 73014-3040-6	453 g in 1 JAR; Type 0: Not a Combination Product	04/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/08/2019

Labeler - ANCALIMA LIFESCIENCES LIMITED (676760093)