Hydrocortisone by Acme United Corporation HYDROCORTISONE cream

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]

SPL UNCLASSIFIED SECTION

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

• apply to affected area not more than 3 to 4 times daily
• children under 2, consult a doctor

Inactive ingredients

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

Questions

1.800.835.2263

PRINCIPAL DISPLAY PANEL

Box Label

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-1133(NDC:61010-5800)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-1133-00	0.9 g in 1 POUCH; Type 0: Not a Combination Product	05/08/2023
2	NDC: 0924-1133-01	10 in 1 BOX	05/08/2023
2		0.9 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 0924-1133-02	12 in 1 BOX	05/08/2023
3		0.9 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 0924-1133-03	20 in 1 BOX	05/08/2023
4		0.9 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 0924-1133-04	25 in 1 BOX	05/08/2023
5		0.9 g in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 0924-1133-05	100 in 1 BOX	05/08/2023
6		0.9 g in 1 POUCH; Type 0: Not a Combination Product
7	NDC: 0924-1133-06	144 in 1 BOX	05/08/2023
7		0.9 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/08/2023

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		045924339	relabel(0924-1133) , repack(0924-1133)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	relabel(0924-1133) , repack(0924-1133)