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

Purpose

Anti-itch

Description

Drug Facts


Medication Information

Warnings

For external use only

Purpose

Anti-itch

Inactive Ingredients

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

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

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%

Keep Out of Reach of Children.

If swallowed, contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only

Purpose

Anti-itch

Inactive Ingredients (Inactive ingredients)

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

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

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%

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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