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NDC 70000-0495-01 Hydrocortisone With Aloe 1 g/100g Details

Hydrocortisone With Aloe 1 g/100g

Hydrocortisone With Aloe is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 70000. The primary component is HYDROCORTISONE.

MedlinePlus Drug Summary

Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Related Packages: 70000-0495-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	70000-0495
Product ID	70000-0495_4d4dbf1f-adb3-4576-a3c3-181a5f868e09
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 With Aloe
Proprietary Name Suffix	Maximum Strength
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	Cardinal Health (Leader) 70000
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	n/a

Package

Package Images

NDC 70000-0495-01 (70000049501)

Pricing Information	N/A
NDC Package Code	70000-0495-1
Billing NDC	70000049501
Package	1 TUBE in 1 CARTON (70000-0495-1) / 28 g in 1 TUBE
Marketing Start Date	2019-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ebe9d772-3a74-441a-8d40-0597e1224340 Details

Drug Facts

Active ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

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
jewelry
detergents
cosmetics
psoriasis
seborrheic dermatitis
for external genital, feminine and anal itching
other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

for external feminine itching if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.

When using this product

avoid contact with the eyes
do not begin the use of any other hydrocortisone product unless directed by a doctor
for external anal itching:
- do not use more than directed unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

symptoms last for more than 7 days
the condition gets worse
symptoms clear up and occur again in a few days
rectal bleeding occurs, consult doctor promptly

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center 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

For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor

Other information

Store at room temperature 59°-86°F (15°-30°C). Protect from freezing.
Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax. May contain citric acid or sodium citrate solution to adjust pH.

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday–Friday.

PRINCIPAL DISPLAY PANEL

Leader™

NDC 70000-0495-1

Maximum Strength

Hydrocortisone Cream, USP 1% With Aloe

Anti-Itch Cream | Relieves Itches and Rashes

COMPARE TO CORTIZONE•10® active ingredient*

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH

hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0495
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBIC ACID (UNII: X045WJ989B)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WHITE WAX (UNII: 7G1J5DA97F)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0495-1	1 in 1 CARTON	07/01/2019	12/29/2023
1		28 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	07/01/2019	12/29/2023

Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 10/2021

Document Id: 4d4dbf1f-adb3-4576-a3c3-181a5f868e09

Set id: ebe9d772-3a74-441a-8d40-0597e1224340

Version: 4

Effective Time: 20211006