Green Guard Maximum Strength Hydrocortisone Cream 1%

Green Guard Maximum Strength Hydrocortisone Cream 1%
SPL v4
SPL
SPL Set ID bd348e2a-57b1-3f17-e053-2a95a90a8bdc
Route
TOPICAL
Published
Effective Date 2021-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Trolamine Cetyl Alcohol Citric Acid Monohydrate Edetate Disodium Methylparaben Glyceryl Monostearate Diazolidinyl Urea Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Mineral Oil Stearic Acid Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-06-01 Until 2028-04-30
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 and rashes
  • other uses of this product should be only under the advice and supervision of a doctor
Dosage and Administration

Directions

  • adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor
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
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
Section 50567-7

When using this product

  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you've consulted a doctor
Section 50570-1

Do not use for the treatment of diaper rash. Consult a doctor.

Section 51727-6

Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, stearic acid, trolamine, water

Section 51945-4

Maximum Strength

Hydrocortisone cream 1%

Temporary relief of itching associated with minor skin irritations and rashes

Green Guard

Order #3101

0.9 g packets 25 per box

Section 53413-1

Questions or comments? 1-800-869-6970

Section 55105-1

Purpose

Anti-itch cream

Section 55106-9

Active ingredient

Hydrocortisone acetate (equivalent to Hydrocortisone 1 %)

Section 60561-8

Other information

  • clean the affected area
  • store at room temperature (do not freeze)
  • tamper evident. Do not use any opened or torn packets
  • you may report a serious adverse reaction to this product to 800-634-7680

Structured Label Content

Indications and Usage (34067-9)

Uses

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

Directions

  • adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor
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
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes
  • do not begin use of any other hydrocortisone product unless you've consulted a doctor
Section 50570-1 (50570-1)

Do not use for the treatment of diaper rash. Consult a doctor.

Section 51727-6 (51727-6)

Inactive ingredients

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, stearic acid, trolamine, water

Section 51945-4 (51945-4)

Maximum Strength

Hydrocortisone cream 1%

Temporary relief of itching associated with minor skin irritations and rashes

Green Guard

Order #3101

0.9 g packets 25 per box

Section 53413-1 (53413-1)

Questions or comments? 1-800-869-6970

Section 55105-1 (55105-1)

Purpose

Anti-itch cream

Section 55106-9 (55106-9)

Active ingredient

Hydrocortisone acetate (equivalent to Hydrocortisone 1 %)

Section 60561-8 (60561-8)

Other information

  • clean the affected area
  • store at room temperature (do not freeze)
  • tamper evident. Do not use any opened or torn packets
  • you may report a serious adverse reaction to this product to 800-634-7680

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:42.652824 · Updated: 2026-03-14T23:02:24.469183