HYDROCORTISONE- hydrocortisone cream 
Acme United Corp

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.

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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

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 Carton Label

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

Principal Display Panel - 0.9g Packet Label
HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-1132
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-1132-0212 in 1 CARTON
1NDC:0924-1132-010.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:0924-1132-03144 in 1 CARTON
2NDC:0924-1132-010.9 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:0924-1132-0425 in 1 CARTON
3NDC:0924-1132-010.9 g in 1 PACKET; Type 0: Not a Combination Product
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/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(0924-1132)

Revised: 3/2016
Document Id: 47fbceb4-3309-4cba-8a7d-62fb4f7d7b6b
Set id: a996f9c6-7f8b-4a27-8020-3f4fafba9e05
Version: 3
Effective Time: 20160309
 
Acme United Corp