Pio Put It On®

Pio Put It On®
SPL v1
SPL
SPL Set ID a5c30b44-9a6b-478f-9b2c-c71ba63c04e4
Route
TOPICAL
Published
Effective Date 2010-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Ethanol Methylparaben Mineral Oil Paraffin Petrolatum Propylparaben Water White Wax

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-05-01

Description

For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation or Rashes 25 Packets Each Packet Net.Wt.0.9gm

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation or Rashes 25 Packets Each Packet Net.Wt.0.9gm

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, seborrheic dermatitis, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor
Section 42229-5

For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation or Rashes

25 Packets

Each Packet Net.Wt.0.9gm

Warnings
  • For external use only
  • Do not use for the treatment of diaper rash
  • not for external genital, feminine and anal itching
Do Not Use
  • with any other Hydrocortisone product unless you have consulted a doctor • for feminine itching

KEEP OUT OF REACH OF CHILDREN.

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

Directions

  • for adults and children 2 years of age and older apply

    to affected area 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and 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
Active Ingredient

Hydrocortisone 1.0%

Other Information
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets
Inactive Ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Manufactured for: B8 SALES

Cincinnati,Ohio 45215

Principal Display Panel

1% Hydrocortisone Cream – Carton Label

PIO Put it on®

1% Hydrocortisone Cream™

For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation or Rashes

25 Packets

Each Packet Net.Wt.0.9gm

When Using This Product
  • avoid contact with eyes
  • do not put this product into rectum or vagina by using fingers or any mechanical device or applicator
Ask A Doctor Before Use:
  • for external itching, do not exceed the recommended daily dosage, or if bleeding occurs
  • if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Structured Label Content

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, seborrheic dermatitis, psoriasis and scrapes
  • other uses of this product should be only under the advice and supervision of a doctor
Section 42229-5 (42229-5)

For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation or Rashes

25 Packets

Each Packet Net.Wt.0.9gm

Purpose

Anti-itch

Warnings
  • For external use only
  • Do not use for the treatment of diaper rash
  • not for external genital, feminine and anal itching
Do Not Use (Do not use)
  • with any other Hydrocortisone product unless you have consulted a doctor • for feminine itching

KEEP OUT OF REACH OF CHILDREN.

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

Directions

  • for adults and children 2 years of age and older apply

    to affected area 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and 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
Active Ingredient (Active ingredient)

Hydrocortisone 1.0%

Other Information (Other information)
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets
Inactive Ingredients (Inactive ingredients)

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Manufactured for: B8 SALES

Cincinnati,Ohio 45215

Principal Display Panel

1% Hydrocortisone Cream – Carton Label

PIO Put it on®

1% Hydrocortisone Cream™

For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation or Rashes

25 Packets

Each Packet Net.Wt.0.9gm

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not put this product into rectum or vagina by using fingers or any mechanical device or applicator
Ask A Doctor Before Use: (Ask a doctor before use:)
  • for external itching, do not exceed the recommended daily dosage, or if bleeding occurs
  • if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data


Raw Label Data

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