Cvs Cortisone Cooling Gel 1 Oz 34084 Zdp

Cvs Cortisone Cooling Gel 1 Oz 34084 Zdp
SPL v13
SPL
SPL Set ID 8a4544df-bbba-47d2-ada0-352757abc91f
Route
TOPICAL
Published
Effective Date 2016-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 mg)
Inactive Ingredients
Aloe Vera Leaf Carboxypolymethylene Glycerin Methylparaben Oat Kernel Oil Propylene Glycol Sodium Hydroxide Sorbitan Monostearate Stearyl Alcohol White Wax Water Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-13

Description

Active ingredients                             Purpose Hydrocortisone 1%......................... Anti-itch


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

  • for itching of skin irritation, inflammation, and rashes:
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissure or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor
Dosage and Administration

DISTRIBUTED BY:

ONE CVS DRIVE

WOONSOCKET, RI 02895 USA

Description

Active ingredients                             Purpose Hydrocortisone 1%......................... Anti-itch

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
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

  • stop use and ask a doctor if
  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs
Section 50567-7

When using this product

  • avoid contact with the eyes
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
Section 50570-1

Do not use

  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
  • more than directed unless directed by a doctor
Section 51727-6

Inactive ingredients

aloe vera leaf, carboxypolymethylene, glycerin, methylparaben, oat kernel oil, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol, water, white wax

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

  • eczema
  • insect bites
  • poison ivy
  • posion oak
  • poison sumac
  • soaps
  • jewlery
  • detergents
  • cosmetics
  • psoriasis
  • seborrheic dematitis
  • temporarily relievs external anal and genital itching
  • other uses of this product should be only under the advice and supervision of a doctor
Section 55106-9

Active ingredients                             Purpose

Hydrocortisone 1%......................... Anti-itch


Structured Label Content

Indications and Usage (34067-9)

Directions

  • for itching of skin irritation, inflammation, and rashes:
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissure or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor
Dosage and Administration (34068-7)

DISTRIBUTED BY:

ONE CVS DRIVE

WOONSOCKET, RI 02895 USA

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
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

  • stop use and ask a doctor if
  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs
Section 50567-7 (50567-7)

When using this product

  • avoid contact with the eyes
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
Section 50570-1 (50570-1)

Do not use

  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
  • more than directed unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients

aloe vera leaf, carboxypolymethylene, glycerin, methylparaben, oat kernel oil, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol, water, white wax

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

  • eczema
  • insect bites
  • poison ivy
  • posion oak
  • poison sumac
  • soaps
  • jewlery
  • detergents
  • cosmetics
  • psoriasis
  • seborrheic dematitis
  • temporarily relievs external anal and genital itching
  • other uses of this product should be only under the advice and supervision of a doctor
Section 55106-9 (55106-9)

Active ingredients                             Purpose

Hydrocortisone 1%......................... Anti-itch


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)