HYDROCORTISONE- anti-itch cream ointment 
Acme United Corporation

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First Aid Only Hydrocortisone 1% Anti-Itch Cream

Active ingredient

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Purpose

Anti-itch

Uses

  • temporarily relieves itching associated with minor skin irritations and rashes
  • other uses should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

Do not use ▪ in or near eyes

▪ for a diaper rash. Consult a doctor.

When using this product

  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you've consulted a doctor

Stop use and ask a doctor if

  • Stop use and ask a doctor if ▪ condition worsens or symptoms persist for more than 7 days

    ▪ symptoms clear up and occur again within a few days

Keep out of the reach of children

If swallowed get medical help or contact poison control (800-222-1222) right away.

Directions

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years; do not use, consult a doctor

Other information

  • store at room temperature

Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylparaben, purified water, stearic acid, trolamine

Questions ?

1.800.835.2263

Carton Image

HYDROCORTISONE 
anti-itch cream ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5632(NDC:59898-800)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYETHYLENE GLYCOL 10000 (UNII: H57W405143)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-5632-0320 in 1 CARTON12/20/2019
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:0924-5632-0425 in 1 CARTON12/20/2019
20.9 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:0924-5632-0110 in 1 CARTON12/20/2019
30.9 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:0924-5632-000.9 g in 1 PACKET; Type 0: Not a Combination Product12/20/2019
5NDC:0924-5632-0212 in 1 CARTON12/20/2019
50.9 g in 1 PACKET; Type 0: Not a Combination Product
6NDC:0924-5632-0560 in 1 CARTON12/20/2019
60.9 g in 1 PACKET; Type 0: Not a Combination Product
7NDC:0924-5632-06144 in 1 CARTON12/20/2019
70.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/20/201904/30/2025
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-5632) , repack(0924-5632)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(0924-5632) , repack(0924-5632)

Revised: 6/2025
Document Id: 3802a816-73d6-2997-e063-6294a90a2177
Set id: 9a161e39-ce64-6399-e053-2a95a90ab36b
Version: 3
Effective Time: 20250620
 
Acme United Corporation