Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 8d65e945-2557-486f-9279-ecbaa08f31c4
Route
TOPICAL
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Water Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Glycerin Isopropyl Myristate Cyclomethicone 5 Benzyl Alcohol Cetyl Palmitate Isostearyl Neopentanoate Citric Acid Monohydrate Potassium Lactate Potassium Sorbate Deanol Peg-40 Stearate Methylparaben Aloe Vera Leaf Niacinamide Oat Sodium Lauroyl Lactylate Hyaluronate Sodium Sodium Benzoate Phenoxyethanol Tanacetum Parthenium Ceramide 3 Ceramide 6 Ii Phytosphingosine Cholesterol Xanthan Gum Maltodextrin Ceramide 1 Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-14

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, soaps, detergents, cosmetics, seborrheic dermatitis, psoriasis
  • other uses of this product should only be under the advice and supervision of a doctor
Section 51945-4

Warnings

For external use only

Questions

Toll-free number 1-888-768-2915

www.CeraVe.com

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, ask a doctor
Do Not Uses

for the treatment of diaper rash. Consult a doctor.

Active Ingredient

Hydrocortisone 1%

Other Information

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

water, cetearyl alcohol, glycerin, ceteareth-20, isopropyl myristate, cyclopentasiloxane, benzyl alcohol, isostearyl neopentanoate, cetyl palmitate, PEG-40 stearate,. potassium lactate, ceramide NP, ceramide AP, potassium sorbate,. ceramide EOP, carbomer, niacinamide, dimethicone/vinyltrimethylsiloxysilicate crosspolymer, dimethyl MEA, aloe barbadensis leaf juice, methylparaben, sodium lauroyl lactylate, sodium hyaluronate, sodium benzoate, cholesterol, avena sativa (oat) kernel extract, phenoxyethanol, citric acid, phytosphingosine, xanthan gum, maltodextrin, chrysanthemum parthenium (feverfew) extract, ethylhexylglycerin

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If

if condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, soaps, detergents, cosmetics, seborrheic dermatitis, psoriasis
  • other uses of this product should only be under the advice and supervision of a doctor
Section 51945-4 (51945-4)

Purpose

Anti-itch

Warnings

For external use only

Questions

Toll-free number 1-888-768-2915

www.CeraVe.com

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, ask a doctor
Do Not Uses (Do not uses)

for the treatment of diaper rash. Consult a doctor.

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

water, cetearyl alcohol, glycerin, ceteareth-20, isopropyl myristate, cyclopentasiloxane, benzyl alcohol, isostearyl neopentanoate, cetyl palmitate, PEG-40 stearate,. potassium lactate, ceramide NP, ceramide AP, potassium sorbate,. ceramide EOP, carbomer, niacinamide, dimethicone/vinyltrimethylsiloxysilicate crosspolymer, dimethyl MEA, aloe barbadensis leaf juice, methylparaben, sodium lauroyl lactylate, sodium hyaluronate, sodium benzoate, cholesterol, avena sativa (oat) kernel extract, phenoxyethanol, citric acid, phytosphingosine, xanthan gum, maltodextrin, chrysanthemum parthenium (feverfew) extract, ethylhexylglycerin

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

if condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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