Xpect Hydrocortisone — v3

Xpect Hydrocortisone

4 Views

Version

v3

Effective date

September 26, 2025

Original packager

Yes

Sections captured

13

Identifiers

Document ID
1dc033fa-b07c-4fe8-b9d6-8a92c831bf4e
Set ID
45ef9be4-54c4-4d85-966b-27708313ded4
Application numbers
M017
Product NDCs
42961-237
Package NDCs
42961-237-01, 42961-237-02, 42961-237-03, 42961-237-04
Original packager NDCs
—

Names & Manufacturers

Brand names
Xpect Hydrocortisone
Generic names
HYDROCORTISONE
Manufacturer names
Cintas Corporation
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
HYDROCORTISONE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
Corticosteroid [EPC]
Pharmacologic class (CS)
—
Mechanism of action
Corticosteroid Hormone Receptor Agonists [MoA]

Other identifiers

NUI
N0000175450, N0000175576
RxCUI
106258
UNII
WI4X0X7BPJ
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients (in each gram) Hydrocortisone 1%
Do Not Use (1)

Sequence 1

Do not use for the treatment of diaper rash in eyes for feminine itching
Dosage And Administration (1)

Sequence 1

Directions for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily children under 12 years of age: for external anal itching, consult a doctor children under 2: do not use, consult a doctor adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Inactive Ingredient (1)

Sequence 1

Inactive ingredients cetyl alcohol*, citric acid*, diazolidinyl urea*, edetate disodium*, emulsifying wax*, ethanol*, glycerin*, glyceryl monostearate*, methylparaben, mineral oil, paraffin*, petrolatum*, polyethylene glycol*, propylene glycol*, propylparaben, stearic acid*, trolamine*, water, white wax* *may contain ingredient
Indications And Usage (1)

Sequence 1

Uses for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes other uses of product should be only under the advice and supervision of a doctor
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other Safety Information (1)

Sequence 1

Other Information clean the affected area store at room temperature (do not freeze) do not use any opened or torn packets
Package Label Principal Display Panel (2)

Sequence 1

Principal Display Panel 42961-235-02 HYDROCORTISONE Active Ingredient: Hydrocortisone 1% Anti-itch cream For temporary relief of itching associated with minor skin irritations, inflammation, or rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, and other skin irritations. Distributed by: Cintas • Mason, OH 45040 • www.cintas.com Xpect® First aid NET WT PER PKT 1/32 OZ (0.9g) 10 Packets per Box 10_CT_BOX

Sequence 2

Principal Display Panel 42961-235-03 HYDROCORTISONE Hydrocortisone 1% Anti-itch cream For temporary relief of itching associated with minor skin irritations, inflammation, or rashes. Xpect® First aid Distributed by: Cintas • Mason, OH 45040 • www.cintas.com NET WT PER PKT 1/32 OZ (0.9g) 20 Packets per Box 20_CT_BOX
Purpose (1)

Sequence 1

Purpose Anti-itch cream
Questions (1)

Sequence 1

Questions? 1-877-973-2811 M-F 8 am - 5 pm
Spl Product Data Elements (1)

Sequence 1

Xpect Hydrocortisone Hydrocortisone HYDROCORTISONE HYDROCORTISONE METHYLPARABEN MINERAL OIL PARAFFIN PETROLATUM PROPYLPARABEN WATER ALCOHOL CETOSTEARYL ALCOHOL POLYSORBATE 60 PEG-150 DISTEARATE STEARETH-20
Stop Use (1)

Sequence 1

Stop use and ask a doctor if condition worsens or lasts more than 7 days, or clears up and ocurs again within a few days you begin use of any other Hydrocortisone product unless you have consulted a doctor if bleeding occurs
Warnings (1)

Sequence 1

Warnings For external use only. Do not use for the treatment of diaper rash in eyes for feminine itching Stop use and ask a doctor if condition worsens or lasts more than 7 days, or clears up and ocurs again within a few days you begin use of any other Hydrocortisone product unless you have consulted a doctor if bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OpenFDA raw payload

{'application_number': ['M017'],
 'brand_name': ['Xpect Hydrocortisone'],
 'generic_name': ['HYDROCORTISONE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Cintas Corporation'],
 'nui': ['N0000175576', 'N0000175450'],
 'package_ndc': ['42961-237-01',
                 '42961-237-02',
                 '42961-237-03',
                 '42961-237-04'],
 'pharm_class_epc': ['Corticosteroid [EPC]'],
 'pharm_class_moa': ['Corticosteroid Hormone Receptor Agonists [MoA]'],
 'product_ndc': ['42961-237'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['106258'],
 'spl_id': ['1dc033fa-b07c-4fe8-b9d6-8a92c831bf4e'],
 'spl_set_id': ['45ef9be4-54c4-4d85-966b-27708313ded4'],
 'substance_name': ['HYDROCORTISONE'],
 'unii': ['WI4X0X7BPJ']}