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Hydrocortisone by Acme United Corp

Dosage form: cream
Ingredients: Hydrocortisone 10mg in 1g
Labeler: Acme United Corp
NDC Code: 0924-1132

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Principal Display Panel - 0.9g Carton Label

18-012
MISC

FIRST AID ONLY®

Hydrocortisone
Anti-Itch Cream
12 (0.9g) Packets

Ungüento con hidrocortisona para aliviar la comezón
12 sobres de (0.9g)

Principal Display Panel - 0.9g Packet Label

Anti-Itch
Cream

0.9g (1/32 oz)

FIRST AID ONLY®

www.FirstAidOnly.com

Fairfield, CT 06824

1.800.835.2263

©2015 Acme United Corporation. 810002-revA

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-1132
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
alcohol 
methylparaben 
mineral oil 
paraffin 
petrolatum 
propylparaben 
water 
white wax 
Packaging
#Item CodePackage Description
1NDC:0924-1132-0212 PACKET in 1 CARTON
1NDC:0924-1132-010.9 g in 1 PACKET
2NDC:0924-1132-03144 PACKET in 1 CARTON
2NDC:0924-1132-010.9 g in 1 PACKET
3NDC:0924-1132-0425 PACKET in 1 CARTON
3NDC:0924-1132-010.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/06/2015
Labeler - Acme United Corp (001180207)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(0924-1132)

 
Acme United Corp

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Medically reviewed on Mar 9, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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