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NDC 67234-0010-01 Natureplex Hydrocortisone 0.01 g/g Details

Natureplex Hydrocortisone 0.01 g/g

Natureplex Hydrocortisone is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Natureplex, LLC. 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: 67234-0010-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	67234-0010
Product ID	67234-010_da2660d2-8e1a-486d-acb1-043266c9473e
Associated GPIs	90550075003720
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	Natureplex Hydrocortisone
Proprietary Name Suffix	Hydro
Non-Proprietary Name	Hydrocortisone
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	0.01
Active Ingredient Units	g/g
Substance Name	HYDROCORTISONE
Labeler Name	Natureplex, LLC
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	2024-12-31

Package

Package Images

NDC 67234-0010-01 (67234001001)

Pricing Information	N/A
NDC Package Code	67234-010-01
Billing NDC	67234001001
Package	28 g in 1 TUBE (67234-010-01)
Marketing Start Date	2008-01-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2fc6a148-34bb-4289-8588-32c1bb011b98 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Antipruritic (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, detergents, cosmetics, jewelry
and for external anal and genital itching

Warnings

For external use only.

Avoid contact with eyes.

Do Not Use

if you have a vaginal discharge. Consult a doctor.

When using this product

do not exceed the recommended daily dosage unless directed by a doctor
do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
beeding occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

For itching associated with minor skin irritations, inflammation, and rashes:

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

For external anal and genital itching:

Adults and children 12 years of age and older:

when practical, cleanse the affected area with mild soap or 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
apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: Consult a doctor

Other information

store at 15 to 30°C (59 to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Natureplex™

MAXIMUM STRENGTH

Hydrocortisone Cream

Fast Itch And Rash Relief!

NET WT. 1 Oz. (28g)

Principal Display Panel - 28 g Tube Carton

INGREDIENTS AND APPEARANCE

NATUREPLEX HYDROCORTISONE HYDRO

hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67234-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)	Hydrocortisone	0.01 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Aloe Vera Leaf (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
cetyl alcohol (UNII: 936JST6JCN)
DMDM Hydantoin (UNII: BYR0546TOW)
glyceryl monostearate (UNII: 230OU9XXE4)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
polysorbate 20 (UNII: 7T1F30V5YH)
propylparaben (UNII: Z8IX2SC1OH)
stearic acid (UNII: 4ELV7Z65AP)
trolamine (UNII: 9O3K93S3TK)
edetate trisodium (UNII: 420IP921MB)
water (UNII: 059QF0KO0R)
alcohol (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67234-010-01	28 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/22/2008

Labeler - Natureplex, LLC (062808196)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex, LLC		062808196	manufacture(67234-010)

Revised: 11/2017

Document Id: da2660d2-8e1a-486d-acb1-043266c9473e

Set id: 2fc6a148-34bb-4289-8588-32c1bb011b98

Version: 13

Effective Time: 20171130