First Aid Only Hydocortisone 1% Anti-itch Cream

First Aid Only Hydocortisone 1% Anti-itch Cream
SPL v2
SPL
SPL Set ID e5597b11-b08e-99e1-e053-2a95a90a15a5
Route
TOPICAL
Published
Effective Date 2022-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Ceteth-20 Cetostearyl Alcohol Mineral Oil Chlorocresol Propylene Glycol Water Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-08-02

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses

Uses ▪ temporarily relieves itching associated with minor skin irritations and rashes

▪other uses should be only under the advice and supervision of a doctor

Section 42229-5

Questions 1.800.835.2263

Section 50565-1

Keep out of reach of children.If swallowed get medical help or contact poison control (800-222-1222) right away.

Section 51945-4

Carton image

Warnings

For external use only.

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, consult a doctor

Do Not Use

for a diaper rash. Consult a doctor.

Active Ingredient

Hydrocortisone 1%

Other Information
  • Store at 15° to 30°C (59° to 86°F)
Inactive Ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, soft paraffin

When Using This Product
  • Avoid contact with the eyes
  • Do not begin use of any other Hydrocortisone product unless you have asked a doctor
Stop Use and Ask A Doctor If

▪ condition worsens or symptoms persist for more than 7 days

▪ symptoms clear up and occur again within a few days


Structured Label Content

Uses (USES)

Uses ▪ temporarily relieves itching associated with minor skin irritations and rashes

▪other uses should be only under the advice and supervision of a doctor

Section 42229-5 (42229-5)

Questions 1.800.835.2263

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed get medical help or contact poison control (800-222-1222) right away.

Section 51945-4 (51945-4)

Carton image

Purpose (PURPOSE)

Anti-Itch

Warnings (WARNINGS)

For external use only.

Directions (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, consult a doctor

Do Not Use (Do not use)

for a diaper rash. Consult a doctor.

Active Ingredient (ACTIVE INGREDIENT)

Hydrocortisone 1%

Other Information (OTHER INFORMATION)
  • Store at 15° to 30°C (59° to 86°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, soft paraffin

When Using This Product (When using this product)
  • Avoid contact with the eyes
  • Do not begin use of any other Hydrocortisone product unless you have asked a doctor
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

▪ condition worsens or symptoms persist for more than 7 days

▪ symptoms clear up and occur again within a few days


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)