Label at a glance#

ProductDABUR ZINC OXIDE 3.8%

Active ingredientZINC OXIDE

Label structure10 sections

Indications and 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

Dosage and administration

■ Change wet and 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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 3.8%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

■ 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

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

■ Avoid contact with eyes ■ If eye contact, occurs, flush with water

Stop Use and ask a doctor if

OTC - STOP USE SECTION

■ condition worsens or doesn't improve within seven days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Change wet and 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

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Gel, Alpha Tocopherol (Vitamin E), Cholecalciferol (Vitamin D), Chloroxylenol, Cetostearyl Alcohol, Corn Oil, Ethylhexylglycerin, FD&C Yellow No. 5, FD&C Yellow No. 6, Fragrance, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Microcrystalline wax, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Borate, Sodium Laureth-3 Sulfate, Stearic Acid, Vitamin A Palmitate, Water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact Panel

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1089065	Zinc oxide (Topical)	zinc oxide 0.038 MG/MG Topical Ointment	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1089065	zinc oxide 3.8 % Topical Ointment	PSN	1
1089065	zinc oxide 0.038 MG/MG Topical Ointment	SCD	1
1089065	ZNO 0.038 MG/MG Topical Ointment	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68747-8020-0	DABURZINC OXIDE 3.8%	100 g in 1 TUBE	OINTMENT	100		1
68747-8020-4	DABURZINC OXIDE 3.8%	452 g in 1 JAR	OINTMENT	452		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68747-8020	DABUR ZINC OXIDE 3.8% (ZINC OXIDE) OINTMENT [DABUR INDIA LIMITED]	1	Current NDC, 2 package rows	20240922_2290bbe2-8a88-b94e-e063-6294a90a7e38.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

DABUR ZINC OXIDE 3.8%
ZINC OXIDE
FD&C YELLOW NO. 5
GLYCERYL MONOSTEARATE
ALOE VERA LEAF
CHLOROXYLENOL
CHOLECALCIFEROL
CORN OIL
LANOLIN
MINERAL OIL
PARAFFIN
PHENOXYETHANOL
VITAMIN A PALMITATE
SODIUM BORATE
ALPHA-TOCOPHEROL
ETHYLHEXYLGLYCERIN
SODIUM LAURETH-3 SULFATE
STEARIC ACID
GLYCERIN
CETOSTEARYL ALCOHOL
MICROCRYSTALLINE WAX
ISOPROPYL MYRISTATE
WATER
FD&C YELLOW NO. 6
FOOD YELLOW 3 FREE ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68747-8020	68747-8020-4, 68747-8020-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C YELLOW NO. 5	I753WB2F1M	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
CHLOROXYLENOL	0F32U78V2Q	IACT
CHOLECALCIFEROL	1C6V77QF41	IACT
CORN OIL	8470G57WFM	IACT
LANOLIN	7EV65EAW6H	IACT
MINERAL OIL	T5L8T28FGP	IACT
PARAFFIN	I9O0E3H2ZE	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
SODIUM LAURETH-3 SULFATE	BPV390UAP0	IACT
STEARIC ACID	4ELV7Z65AP	IACT
GLYCERIN	PDC6A3C0OX	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
WATER	059QF0KO0R	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DABUR ZINC OXIDE 3.8%	ZINC OXIDE	Dabur India Limited	2290bbe2-8a88-b94e-e063-6294a90a7e38	2024-09-20	Warnings	Exact identifier ndc (package): 68747-8020-0 ndc (package): 68747-8020-4 ndc (product): 68747-8020 ndc11 (package): 68747802000 ndc11 (package): 68747802004 spl id: 2290acb3-50a3-7d6d-e063-6394a90ae409 spl set id: 2290bbe2-8a88-b94e-e063-6294a90a7e38

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DABUR