SPL v2
SPL
SPL Set ID 1108aa35-b9c2-0553-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2015-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (9 mg)
Inactive Ingredients
Alcohol Isopropyl Alcohol Water Glycerin Laureth-4 Tert-butyl Alcohol Brucine Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-07-01

Description

Hydrocortisone

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone

Use

•Specially formulated to rapidly and completely penetrate the skin delivering itch relief anywhere it's needed. •This liquid preparation can be applied to the skin or scalp to temporarily relieve minor itching and skin irritations commonly associated with insect bites, poison ivy, poison oak, poison sumac, and skin blemishes.

Section 51945-4

Loesch EST.1951

PROFESSIONALS

HC-10 ANTI-ITCH THERAPY

RELIEVES THE ITCHING OF

SKIN IRRITATIONS

SCALP BLEMISHES

POISION IVY

POISON OAK

POISON SUMAC

INSECT BITES

NDC 25280-008-02

CONTENTS 2 FL. OZ. (59.2 ML.)

Warnings

•Not for use on children under 2 years old except as directed by a pediatrician. •Avoid contact with eyes and mucous membranes. •Do not apply to large areas of the body and do not use for extended periods of time. •For external use only. •If irritation develops and persists, discontinue use and ask a doctor. •When using this product, if condition worsens or if symptoms persists for more than 7 days or clear up and occur again within a few days, stop use and ask a doctor.

Directions

•Apply this product topically to affected areas and allow to dry without rubbing. •Use up to 3 times daily. •Use only as directed.

Active Ingredient

Hydrocortisone

Other Information

• External antipruritic

Inactive Ingredients

•Alcohol, Water, Isopropyl Alcohol, Glycerin, Laureth 4, Tert-Butyl Alcohol, Brucine Sulfate.

Questions Or Comments

Loesch Laboratory Consultants, Inc.

4311 South Dr., Houston, TX 77053-4820

800.231.7157

8 am - 5 pm M-F

www.loeschlab.com

Questions or Comments

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Use

•Specially formulated to rapidly and completely penetrate the skin delivering itch relief anywhere it's needed. •This liquid preparation can be applied to the skin or scalp to temporarily relieve minor itching and skin irritations commonly associated with insect bites, poison ivy, poison oak, poison sumac, and skin blemishes.

Section 51945-4 (51945-4)

Loesch EST.1951

PROFESSIONALS

HC-10 ANTI-ITCH THERAPY

RELIEVES THE ITCHING OF

SKIN IRRITATIONS

SCALP BLEMISHES

POISION IVY

POISON OAK

POISON SUMAC

INSECT BITES

NDC 25280-008-02

CONTENTS 2 FL. OZ. (59.2 ML.)

Purpose

Anti-Itch

Warnings

•Not for use on children under 2 years old except as directed by a pediatrician. •Avoid contact with eyes and mucous membranes. •Do not apply to large areas of the body and do not use for extended periods of time. •For external use only. •If irritation develops and persists, discontinue use and ask a doctor. •When using this product, if condition worsens or if symptoms persists for more than 7 days or clear up and occur again within a few days, stop use and ask a doctor.

Directions

•Apply this product topically to affected areas and allow to dry without rubbing. •Use up to 3 times daily. •Use only as directed.

Active Ingredient

Hydrocortisone

Other Information (Other information)

• External antipruritic

Inactive Ingredients

•Alcohol, Water, Isopropyl Alcohol, Glycerin, Laureth 4, Tert-Butyl Alcohol, Brucine Sulfate.

Questions Or Comments (Questions or Comments)

Loesch Laboratory Consultants, Inc.

4311 South Dr., Houston, TX 77053-4820

800.231.7157

8 am - 5 pm M-F

www.loeschlab.com

Questions or Comments

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)