Hydrocortisone 1%

Hydrocortisone 1%
SPL v11
SPL
SPL Set ID d01d3dbd-afe6-4e62-853c-84c524b99296
Route
TOPICAL
Published
Effective Date 2010-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Cetyl Alcohol Glycerin Squalane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-12-15

Description

Active Ingredient Hydrocortisone 1%


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use



    * in or near the eyes

    * by putting directly into the rectum by using figers or any mechanical device

      or applicator

    * for diaper rash; ask a doctor

Indications and Usage

Uses

temporarily relieves itching

associated with minor skin irritation, inflammation and rashes due to :



  •   psoriasis
  •   seborrheic dermatitis
  •   poison ivy,oak,sumac
  •   insect bites



Other uses of this product: ask a doctor

Dosage and Administration

Directions

  • apply to affected area not more than 3 to 4 time daily
  • for external anal itching: when practical, clean area with mild soap and warm

Description

Active Ingredient Hydrocortisone 1%

Section 50565-1

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control

Section 51727-6

Inactive ingredients

Cetyl alcohol, Buthylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myreistoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water

Hydrocortosone

Section 51945-4
Section 55105-1

Purpose

Anti-itch

Section 55106-9
Active Ingredient

Hydrocortisone 1%






Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves itching

associated with minor skin irritation, inflammation and rashes due to :



  •   psoriasis
  •   seborrheic dermatitis
  •   poison ivy,oak,sumac
  •   insect bites



Other uses of this product: ask a doctor

Dosage and Administration (34068-7)

Directions

  • apply to affected area not more than 3 to 4 time daily
  • for external anal itching: when practical, clean area with mild soap and warm

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use



    * in or near the eyes

    * by putting directly into the rectum by using figers or any mechanical device

      or applicator

    * for diaper rash; ask a doctor

Section 50565-1 (50565-1)

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control

Section 51727-6 (51727-6)

Inactive ingredients

Cetyl alcohol, Buthylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myreistoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water

Hydrocortosone

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Purpose

Anti-itch

Section 55106-9 (55106-9)
Active Ingredient

Hydrocortisone 1%






Advanced Ingredient Data


Raw Label Data

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