DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Hydrocortisone (1 g)

Inactive Ingredients

Aloe Vera Leaf Synthetic Beeswax Calcium Acetate Cetostearyl Alcohol Glycerin Maltodextrin Methylparaben Mineral Oil Propylparaben Sodium Cetostearyl Sulfate Sodium Lauryl Sulfate Water White Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2019-07-01

Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use

in the genital area if you have a vaginal discharg. Consult a doctor.
for the treatment of diaper rash. Consult a doctor

When using this product

avoid contact with the eyes
do not use more than directed unless told to do so by a doctor
do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

condition worsen, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
rectal bleeding occurs

Indications and Usage

Uses

temproarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
eczema
psoriasis
poison ivy, oak, sumac
insect bites
detergents
jewlery
cosmetics
soaps
seborrheic dermatitis
temporarily relieves extranal anal and genital itching
other uses of this product should only be under the advice and supervision of a doctor

Dosage and Administration

Directions

for itchin of skin irritiation, inflammation and rashes:
adults and children 2 years of agea and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: ask a doctor
for external anal and genital itching, adults
when practical, clean the affected area with mild soap and warm water and rinse thouroghly
gently dry by patting or blotting with toilet tissue or a soft cloth before applying
apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Description

Active Ingredient Hydrocortisone 1%

Section 50565-1

Keep out of reach of children

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

Section 51727-6

Inactive ingredients

aloe barbadensis leaf juice, beeswax, clacium acetate, cetearyl alcohol, glycerin, maltodextrin, mehtylparaben, mineral oil, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water, white petrolatum

Section 51945-4

Section 53413-1

Questions

www.menperdistributors.com or 1-800-560-5223 M-F 9 am - 4 pm EST

Section 55105-1

Purpose

Anti-itch

Section 55106-9

Active Ingredient

Hydrocortisone 1%

Structured Label Content

Indications and Usage (34067-9)

Uses

temproarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
eczema
psoriasis
poison ivy, oak, sumac
insect bites
detergents
jewlery
cosmetics
soaps
seborrheic dermatitis
temporarily relieves extranal anal and genital itching
other uses of this product should only be under the advice and supervision of a doctor

Dosage and Administration (34068-7)

Directions

for itchin of skin irritiation, inflammation and rashes:
adults and children 2 years of agea and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: ask a doctor
for external anal and genital itching, adults
when practical, clean the affected area with mild soap and warm water and rinse thouroghly
gently dry by patting or blotting with toilet tissue or a soft cloth before applying
apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use

in the genital area if you have a vaginal discharg. Consult a doctor.
for the treatment of diaper rash. Consult a doctor

When using this product

avoid contact with the eyes
do not use more than directed unless told to do so by a doctor
do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

condition worsen, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
rectal bleeding occurs

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 51727-6 (51727-6)

Inactive ingredients

aloe barbadensis leaf juice, beeswax, clacium acetate, cetearyl alcohol, glycerin, maltodextrin, mehtylparaben, mineral oil, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water, white petrolatum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions

www.menperdistributors.com or 1-800-560-5223 M-F 9 am - 4 pm EST

Section 55105-1 (55105-1)

Purpose

Anti-itch

Section 55106-9 (55106-9)

Active Ingredient

Hydrocortisone 1%

Advanced Ingredient Data

[{"name": "HYDROCORTISONE", "unii": "WI4X0X7BPJ", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SYNTHETIC BEESWAX", "unii": "08MNR5YE2R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM ACETATE", "unii": "Y882YXF34X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CETOSTEARYL SULFATE", "unii": "7ZBS06BH4B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temproarily relieves itching associated with minor skin irritations, inflammation and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewlery cosmetics soaps seborrheic dermatitis temporarily relieves extranal anal and genital itching other uses of this product should only be under the advice and supervision of a doctor", "34068-7": "Directions for itchin of skin irritiation, inflammation and rashes: adults and children 2 years of agea and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults when practical, clean the affected area with mild soap and warm water and rinse thouroghly gently dry by patting or blotting with toilet tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor ", "34071-1": "Warnings For external use only. Do not use in the genital area if you have a vaginal discharg. Consult a doctor. for the treatment of diaper rash. Consult a doctor When using this product avoid contact with the eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsen, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs", "50565-1": "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive ingredients aloe barbadensis leaf juice, beeswax, clacium acetate, cetearyl alcohol, glycerin, maltodextrin, mehtylparaben, mineral oil, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water, white petrolatum", "53413-1": "Questions www.menperdistributors.com or 1-800-560-5223 M-F 9 am - 4 pm EST", "55105-1": "Purpose Anti-itch", "55106-9": "Active Ingredient Hydrocortisone 1%"}