Green Guard Maximum Strength Hydrocortisone Cream 1%

Green Guard Maximum Strength Hydrocortisone Cream 1%
SPL v14
SPL
SPL Set ID 69d6645e-db3c-4dc0-a9a5-e2bc963e2f28
Route
TOPICAL
Published
Effective Date 2022-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2013-04-15 Until 2019-07-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Dosage and Administration

Directions

  • for adults and children (2 years of age and older): apply to affected area 3 to 4 times daily
  • children under 12 years of age: for external anal itching, consult a doctor
  • 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 botting with toilet tissue or a soft cloth before application of this product

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children

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

Section 50566-9

Stop use and ask a doctor if

  • condition worsens or lasts more than 7 days, or clears and occurs again within a few days
  • you begin use of any other Hydrocortisone product unless you have consulted a doctor
  • bleeding occurs
Section 50570-1

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching
Section 51727-6

Inactive ingredient

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

Section 51945-4

Green Guard Hydrocortisone Label

Maximum Strength

Hydrocortisone

cream 1%

Temporary relief of itching associated with minor skin irritation, inflammation and rashes

Green Guard

Order # 3103

25 Per Box

Net Wt 0.9 g (1/32 oz) Packets

Section 53413-1

Questions or comments?

1-800-869-6970

Section 55105-1

Purpose

Anti itch

Section 55106-9

Active ingredient

Hydrocortisone 1.0%

Section 60561-8

Other information

  • store at room temperature (do not freeze)
  • tamper evident, do not use any opened or torn packets

Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes
  • for external genital, feminine and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor
Dosage and Administration (34068-7)

Directions

  • for adults and children (2 years of age and older): apply to affected area 3 to 4 times daily
  • children under 12 years of age: for external anal itching, consult a doctor
  • 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 botting with toilet tissue or a soft cloth before application of this product

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens or lasts more than 7 days, or clears and occurs again within a few days
  • you begin use of any other Hydrocortisone product unless you have consulted a doctor
  • bleeding occurs
Section 50570-1 (50570-1)

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching
Section 51727-6 (51727-6)

Inactive ingredient

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

Section 51945-4 (51945-4)

Green Guard Hydrocortisone Label

Maximum Strength

Hydrocortisone

cream 1%

Temporary relief of itching associated with minor skin irritation, inflammation and rashes

Green Guard

Order # 3103

25 Per Box

Net Wt 0.9 g (1/32 oz) Packets

Section 53413-1 (53413-1)

Questions or comments?

1-800-869-6970

Section 55105-1 (55105-1)

Purpose

Anti itch

Section 55106-9 (55106-9)

Active ingredient

Hydrocortisone 1.0%

Section 60561-8 (60561-8)

Other information

  • store at room temperature (do not freeze)
  • tamper evident, do not use any opened or torn packets

Advanced Ingredient Data


Raw Label Data

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