FIRST AID ONLY HYDROCORTISONE 1% ANTI-ITCH- hydrocortisone cream

First Aid Only Hydrocortisone 1% Anti-Itch by

Drug Labeling and Warnings

First Aid Only Hydrocortisone 1% Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation, Acme United Corpoation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrocortisone 1%

PURPOSE

Anti-Itch

USES

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

for a diaper rash. Consult a doctor.

When using this product

• Avoid contact with the eyes
• Do not begin use of any other Hydrocortisone product unless you have asked a doctor

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 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 of age Do not use, consult a doctor

OTHER INFORMATION

• Store at 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENTS

ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, soft paraffin

SPL UNCLASSIFIED SECTION

Questions 1.800.835.2263

PRINCIPAL DISPLAY PANEL

Carton image

INGREDIENTS AND APPEARANCE

FIRST AID ONLY HYDROCORTISONE 1% ANTI-ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-5633(NDC:50382-024)
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
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MINERAL OIL (UNII: T5L8T28FGP)
CHLOROCRESOL (UNII: 36W53O7109)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-5633-01	12 in 1 CARTON	08/05/2022
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0924-5633-00	0.9 g in 1 PACKET; Type 0: Not a Combination Product	08/05/2022
3	NDC: 0924-5633-02	25 in 1 CARTON	08/05/2022
3		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	08/02/2012

Labeler - Acme United Corporation (001180207)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corpoation		045924339	relabel(0924-5633) , repack(0924-5633)

Establishment
Name	Address	ID/FEI	Business Operations
Acme United Corporation		080119599	repack(0924-5633) , relabel(0924-5633)