SKYLARK- zinc oxide ointment

SKYLARK by

Drug Labeling and Warnings

SKYLARK by is a Otc medication manufactured, distributed, or labeled by Skylark CMC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide 3.8%

Purpose

Skin Protectant

Uses

• Helps treat and prevent rash associated with diaper rash, incontinence or exposure to feces and urine
• Protects skin against irritation due to such rash and
• Helps protect skin from exposure to wetness

Warnings

FOR EXTERNAL USE ONLY

When using this product

• Avoid contact with eyes
• if eye contact occurs, flush with water

Stop use and ask a doctor if

• condition worsens or doesn't improve within seven days

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center rightaway

Directions

• Change wet or soiled diapers promptly
• Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks, lower abdomen and inner thighs
• Allow area to dry
• Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged

Inactive Ingredients

Aloe Barbadensis Gel, Chloroxylenol, Cholecalciferol (Vitamin D3), Zea Mays Oil, Fragrance, Lanolin, Mineral Oil, Paraffin, Phenoxyethanol, Retinyl Palmitate (Vitamin A), Sodium Borate, Tocopherol Acetate (Vitamin E), Water, White Petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKYLARK 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71168-8020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM BORATE (UNII: 91MBZ8H3QO)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
PETROLATUM (UNII: 4T6H12BN9U)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CORN OIL (UNII: 8470G57WFM)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71168-8020-0	100 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2017
2	NDC: 71168-8020-4	452 g in 1 JAR; Type 0: Not a Combination Product	08/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/01/2017

Labeler - Skylark CMC (650174824)