Hydrocortisone Cream

Hydrocortisone Cream
SPL v1
SPL
SPL Set ID e6a0968f-5341-f7e1-e053-2995a90ae952
Route
TOPICAL
Published
Effective Date 2022-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (0.01 g)
Inactive Ingredients
Propylparaben Edetate Disodium Water Trolamine Methylparaben Mineral Oil Cetyl Alcohol Citric Acid Monohydrate Diazolidinyl Urea Glycerin Glyceryl Monostearate Polyethylene Glycol, Unspecified Propylene Glycol Stearic Acid

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-08-19

Description

Hydrocortisone acetate 1%

Purpose

anti-itch cream


Medication Information

Purpose

anti-itch cream

Description

Hydrocortisone acetate 1%

Uses

temporarily relieves itching associated with minor skin irritations and rashes due to:

  • eczema
  • insect bites
  • poison ivy, oak, or sumac
  • soaps, detergents, or cosmetics
  • jewelry
Section 51945-4

Hydrocortisone

1% hydrocortisone anti-itch cream

Net wt per pkt 1/32 oz (0.9 g)

20 pkts per box

Warnings

for external use only

Questions

1-877-973-2811 Monday - Friday 8:00 AM to 5:00 PM

Directions

Adults and children 2 years and over - apply to affected area not more than 3 to 4 times daily

children under 2 years - do not use

Do Not Use
  • with any other hydrocortisone product unless you have consulted a doctor
  • for the treatment of diaper rash, consult a doctor
Other Information
  • do not use if package is torn, cut or opened
  • store at room tempreature (do not freeze)
  • see packet for Lot Number and expiration date
Inactive Ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

When Using This Product

avoid contact with eyes

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Keep Out of Reach of Children

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

Active Ingredients (in Each Packet)

Hydrocortisone acetate 1%


Structured Label Content

Uses

temporarily relieves itching associated with minor skin irritations and rashes due to:

  • eczema
  • insect bites
  • poison ivy, oak, or sumac
  • soaps, detergents, or cosmetics
  • jewelry
Section 51945-4 (51945-4)

Hydrocortisone

1% hydrocortisone anti-itch cream

Net wt per pkt 1/32 oz (0.9 g)

20 pkts per box

Purpose

anti-itch cream

Warnings

for external use only

Questions

1-877-973-2811 Monday - Friday 8:00 AM to 5:00 PM

Directions

Adults and children 2 years and over - apply to affected area not more than 3 to 4 times daily

children under 2 years - do not use

Do Not Use (Do not use)
  • with any other hydrocortisone product unless you have consulted a doctor
  • for the treatment of diaper rash, consult a doctor
Other Information (Other information)
  • do not use if package is torn, cut or opened
  • store at room tempreature (do not freeze)
  • see packet for Lot Number and expiration date
Inactive Ingredients (Inactive ingredients)

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

When Using This Product (When using this product)

avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
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

Active Ingredients (in Each Packet) (Active ingredients (in each packet))

Hydrocortisone acetate 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)