CMC ZINC OXIDE- zinc oxide ointment

CMC ZINC OXIDE by

Drug Labeling and Warnings

CMC ZINC OXIDE by is a Otc medication manufactured, distributed, or labeled by SKYLARK CMC PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide (20% w/w)

Purpose

Skin Protectant

Purpose

• 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

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

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 any time when exposure to wet diapers may be prolonged
• for poison ivy, oak, sumac
• apply ointment liberally as often as needed

Other information

• store at 56°-86° F (15-30°C)
• avoid excessive heat

Inactive ingredients

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

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

CMC ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71168-3040
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
CETETH-20 (UNII: I835H2IHHX)
PETROLATUM (UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71168-3040-3	28 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2017
2	NDC: 71168-3040-4	56 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2017
3	NDC: 71168-3040-5	425 g in 1 JAR; Type 0: Not a Combination Product	09/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2017

Labeler - SKYLARK CMC PRIVATE LIMITED (650174824)