HYDROCORTISONE- anti-itch cream ointment

HYDROCORTISONE by

Drug Labeling and Warnings

HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
anti-itch cream ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-5632(NDC:59898-800)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-5632-03	20 in 1 CARTON	12/20/2019
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0924-5632-04	25 in 1 CARTON	12/20/2019
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0924-5632-01	10 in 1 CARTON	12/20/2019
3		0.9 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0924-5632-00	0.9 g in 1 PACKET; Type 0: Not a Combination Product	12/20/2019
5	NDC: 0924-5632-02	12 in 1 CARTON	12/20/2019
5		0.9 g in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 0924-5632-05	60 in 1 CARTON	12/20/2019
6		0.9 g in 1 PACKET; Type 0: Not a Combination Product
7	NDC: 0924-5632-06	144 in 1 CARTON	12/20/2019
7		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/20/2019

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-5632) , repack(0924-5632)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-5632) , repack(0924-5632)