Hydrocortisone cream

Spl unclassified section

Drug Facts

Active ingredients

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For temporary relief of itching associated with minor skin irritations, inflammation or rashes.

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

Warnings

For external use only

Do not use

  • in eyes
  • for treatment of dipper rash

Stop use, ask a doctor

  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with use of other hydrocortisone products

Keep out of reach of children.

If ingested, contact a Poison Control Center right away

Directions

  • apply to affected area not more than 3 to 5 times daily
  • children under 2: as a doctor

Inactive ingredients

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

Ingredients and appearance - Product information

Hydrocortisone cream- Hydrocortisone

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0924-1132
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydrocortisone ( UNII: WI4X0X7BPJ)( Hydrocortisone - UNII: WI4X0X7BPJ ) 10 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Alcohol ( UNII: 3K9958V90M)
Methylparaben ( UNII: A2I8C7HI9T)
Mineral oil ( UNII: T5L8T28FGP)
Paraffin ( UNII: I9O0E3H2ZE)
Petrolatum ( UNII: 4T6H12BN9U)
Propylparaben ( UNII: Z8IX2SC1OH)
Water ( UNII: 059QF0KO0R)
White wax ( UNII: 7G1J5DA97F)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - Acme United Corp( 001180207)

Establishment

Name ID/FEI Business Operations
Acme United Corp 001180207 MANUFACTURE( 0924-1132)

Principal display panel - 0.9g carton label

18-012
MISC

FIRST AID ONLY ®

Hydrocortisone
Anti-Itch Cream
12 (0.9g) Packets

Ungento con hidrocortisona para aliviar la comezn
12 sobres de (0.9g)

Principal display panel - 0.9g packet label

Anti-Itch
Cream

0.9g ( 1/ 32oz)

FIRST AID ONLY ®

www.FirstAidOnly.com

Fairfield, CT 06824

1.800.835.2263

©2015 Acme United Corporation. 810002-revA