First Aid Only Hydrocortisone 1% Anti-itch Cream

First Aid Only Hydrocortisone 1% Anti-itch Cream
SPL v2
SPL
SPL Set ID fabcaa3b-d189-bd29-e053-6294a90ae86b
Route
TOPICAL
Published
Effective Date 2023-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Alcohol Methylparaben Mineral Oil Paraffin Petrolatum Propylparaben Water Cetostearyl Alcohol Polysorbate 60 Peg-150 Distearate Steareth-20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-08

Description

Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Drug Facts

Uses:

For temporary relief of itching associated with minor skin irritations and rashes.

Other uses of product should be only under the advice and supervision of a doctor

Section 42229-5

Drug Facts

Section 50566-9

Stop use and ask a doctor if

▪ condition worsens or lasts for more than 7 days symptoms clear up and occur again within a few days

▪ you begin using other hydrocortisone products

Section 50570-1
  • Do not use
  • in eyes
  • for diaper rash
Section 51945-4

Box Label

Warnings

For external use only

Questions

1.800.835.2263

Directions:

Adults and children over 2 years of age

  • apply to affected area not more than 3 to 4 times daily
  • children under 2, consult a doctor
Active Ingredient

Hydrocortisone 1.0%

Inactive Ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Keep Out of Reach of Children.

If swallowed, contact a Poison Control Center right away.


Structured Label Content

Uses:

For temporary relief of itching associated with minor skin irritations and rashes.

Other uses of product should be only under the advice and supervision of a doctor

Section 42229-5 (42229-5)

Drug Facts

Section 50566-9 (50566-9)

Stop use and ask a doctor if

▪ condition worsens or lasts for more than 7 days symptoms clear up and occur again within a few days

▪ you begin using other hydrocortisone products

Section 50570-1 (50570-1)
  • Do not use
  • in eyes
  • for diaper rash
Section 51945-4 (51945-4)

Box Label

Purpose

Anti-itch

Warnings

For external use only

Questions

1.800.835.2263

Directions:

Adults and children over 2 years of age

  • apply to affected area not more than 3 to 4 times daily
  • children under 2, consult a doctor
Active Ingredient

Hydrocortisone 1.0%

Inactive Ingredients (Inactive ingredients)

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

If swallowed, contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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