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NDC 00404-0166-50 Hydrocortisone 1 g/100g Details

Hydrocortisone 1 g/100g

Hydrocortisone is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Henry Schein. The primary component is HYDROCORTISONE.

Product Information

NDC	00404-0166
Product ID	0404-0166_eb031535-d17f-9d5e-e053-2a95a90ad3e0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Hydrocortisone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hydrocortisone
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100g
Substance Name	HYDROCORTISONE
Labeler Name	Henry Schein
Pharmaceutical Class	Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00404-0166-50 (00404016650)

Pricing Information	N/A
NDC Package Code	0404-0166-50
Billing NDC	00404016650
Package	72 BOX in 1 CASE (0404-0166-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE
Marketing Start Date	2022-11-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eb031535-d17e-9d5e-e053-2a95a90ad3e0 Details

Active Ingredient

Hydrocortisone USP 1%

Purpose

Antipruritic (Anti-Itch)

Use(s)

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 for external genital, feminine, and anal itching.

Warnings

For External Use Only

If pregnant or breastfeeding, ask a health professional before use

Do not use

• In the eyes

• For diaper rash

• For external genital or feminine itching if you have a vaginal discharge

• More than the recommended daily dosage unless directed by a doctor

• In the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not continue to use this or any other hydrocortisone product for longer that 7 days

• In case of bleeding when used for anal itching

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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: Consult a doctor

• When using for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with bathroom tissue or soft cloth befor applying

• Children under 12: Consult a doctor before using for anal itching

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat

• Tamper Evident. Do not use if seal is damaged.

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

Questions?

1-888-DYNAREX Monday-Friday, 9AM-5PM EST

Label

Hydrocortisone Cream 1%

INGREDIENTS AND APPEARANCE

HYDROCORTISONE

hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0404-0166
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0404-0166-50	72 in 1 CASE	11/07/2022
1		1 in 1 BOX
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/07/2022

Labeler - Henry Schein (012430880)

Revised: 10/2022

Document Id: eb031535-d17f-9d5e-e053-2a95a90ad3e0

Set id: eb031535-d17e-9d5e-e053-2a95a90ad3e0

Version: 1

Effective Time: 20221014