DABUR

Manufacturer
Dabur India Limited
Effective date
2024-09-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:54:21

Label at a glance#

ProductDABUR
Active ingredientHYDROCORTISONE ACETATE
Label structure12 sections

Indications and uses

■ for temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor

Dosage and administration

■ adults and children over 2 years of age ■ apply evenly to affected area no more than 3 to 4 times daily ■ children under 2 years of age ■ do not use, consult a doctor  ■ adults and children over 2 years of age ■ apply evenly to affected area no more than 3 to 4 times daily ■ children under 2 years of age ■ do not use, consult a doctor ■ Adults ■ when practical, cleanse the affected area with mild soap and warm w...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone Acetate USP (1% w/w)

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

■ for temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

■ in the eyes ■ for diaper rash ■ if you have vaginal discharge ■ more than the recommended dosage

Ask a doctor before use

OTC - ASK DOCTOR SECTION

■ if you are pregnant or breast feeding

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again wihin a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults and children over 2 years of age

■ apply evenly to affected area no more than 3 to 4 times daily

■ children under 2 years of age

■ do not use, consult a doctor 

■ adults and children over 2 years of age

■ apply evenly to affected area no more than 3 to 4 times daily

■ children under 2 years of age

■ do not use, consult a doctor

■ Adults

■ when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly

■ gently dry, patting or blotting with bathroom tissue or soft cloth before applying

■ apply externally to the area up to 6 times a daily or after a bowel movement

■ after application discard pad

■ do not flush in toilet

Other information

SPL UNCLASSIFIED SECTION

■ store at 20-25C (68-77F) 

■ avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

 

cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, White white soft paraffin

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68747-305068747-3050-2, 68747-3050-3, 68747-3050-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
22cd5003-935f-5511-e063-6394a90a366222cd3acd-c499-2695-e063-6394a90ab45e2024-09-23WarningsExact identifier
spl id: 22cd5003-935f-5511-e063-6394a90a3662
spl set id: 22cd3acd-c499-2695-e063-6394a90ab45e

Reported adverse events (FAERS/openFDA)#

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