Loesch Anti-itch Therapy

Loesch Anti-itch Therapy
SPL v1
SPL
SPL Set ID 595bf774-2d0f-4316-a328-071c87aae2fe
Route
TOPICAL
Published
Effective Date 2014-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (5 mg)
Inactive Ingredients
Alcohol Water Isopropyl Alcohol Glycerin Laureth-4 Tert-butyl Alcohol Brucine Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-06-26

Description

Hydrocortisone, USP (0.5%)

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone, USP (0.5%)

Use
  • Specially formulated to rapidly and completely penetrate the scalp (or 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 oak, poison sumac, and skin blemishes.
Section 50565-1

Keep out of reach of children.

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, USP (0.5%)

Other Information
  • External antipruritic
Inactive Ingredients:

Ethanol, Purified Water, Isopropyl Alcohol, Glycerin, Laureth 4, t-Butyl Alcohol, Brucine Sulfate

Questions Or Comments?

Loesch Laboratory Consultants, Inc.

4311 South Dr., Houston, TX 77053-4820

800.231.7157 M-F 8am-5pm

Image of 2.0 Fl. Oz. Label

LoeschAntiItchTherapy2oz.jpg


Structured Label Content

Use
  • Specially formulated to rapidly and completely penetrate the scalp (or 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 oak, poison sumac, and skin blemishes.
Section 50565-1 (50565-1)

Keep out of reach of children.

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, USP (0.5%)

Other Information
  • External antipruritic
Inactive Ingredients:

Ethanol, Purified Water, Isopropyl Alcohol, Glycerin, Laureth 4, t-Butyl Alcohol, Brucine Sulfate

Questions Or Comments? (Questions or Comments?)

Loesch Laboratory Consultants, Inc.

4311 South Dr., Houston, TX 77053-4820

800.231.7157 M-F 8am-5pm

Image of 2.0 Fl. Oz. Label

LoeschAntiItchTherapy2oz.jpg


Advanced Ingredient Data


Raw Label Data

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