HYDROCORTISONE- hydrocortisone cream 
Acme United Corporation

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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First Aid Only Hydrocortisone 1% Anti-Itch Cream

Drug Facts

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

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

Warnings

For external use only

  • Do not use
  • in eyes
  • for diaper rash

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

KEEP OUT OF REACH OF CHILDREN.

If swallowed, contact a Poison Control Center right away.

Directions:

Adults and children over 2 years of age

Inactive ingredients

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

Questions

1.800.835.2263

Box Label Box Label

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-1133(NDC:61010-5800)
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)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
STEARETH-20 (UNII: L0Q8IK9E08)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-1133-000.9 g in 1 POUCH; Type 0: Not a Combination Product05/08/2023
2NDC:0924-1133-0110 in 1 BOX05/08/2023
20.9 g in 1 POUCH; Type 0: Not a Combination Product
3NDC:0924-1133-0212 in 1 BOX05/08/2023
30.9 g in 1 POUCH; Type 0: Not a Combination Product
4NDC:0924-1133-0320 in 1 BOX05/08/2023
40.9 g in 1 POUCH; Type 0: Not a Combination Product
5NDC:0924-1133-0425 in 1 BOX05/08/2023
50.9 g in 1 POUCH; Type 0: Not a Combination Product
6NDC:0924-1133-05100 in 1 BOX05/08/2023
60.9 g in 1 POUCH; Type 0: Not a Combination Product
7NDC:0924-1133-06144 in 1 BOX05/08/2023
70.9 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/08/2023
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-1133) , repack(0924-1133)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(0924-1133) , repack(0924-1133)

Revised: 5/2023
Document Id: fabc94c8-eb65-fc70-e053-6394a90af367
Set id: fabcaa3b-d189-bd29-e053-6294a90ae86b
Version: 1
Effective Time: 20230502
 
Acme United Corporation