HYDROCORTISONE- anti-itch cream ointment 
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

Active ingredient

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Purpose

Anti-itch

Uses

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

Other information

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 not finalpart34812/20/2019
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: 12/2019
Document Id: 9a161629-eac9-f40f-e053-2a95a90a368d
Set id: 9a161e39-ce64-6399-e053-2a95a90ab36b
Version: 1
Effective Time: 20191219
 
Acme United Corporation