49314-0005 Unishield Hydrocortisone

49314-0005 Unishield Hydrocortisone
SPL v2
SPL
SPL Set ID 4871a67f-fbb8-4a6b-ace4-d34349028908
Route
TOPICAL
Published
Effective Date 2023-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Water Glycerin Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Ethylhexylglycerin Mineral Oil Petrolatum Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-15

Description

Active ingredient Hydrocortisone 1%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching

When using this product:

  • Keep out of eyes, ears, and mouth
  • In case of contact with eyes, rinse eyes throughly with water

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 other hydrocortisone product unless you have consulted a doctor

bleeding occurs

Indications and Usage

Uses

  • for temorary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, posison 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
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 blotting with toilet tissue or a soft cloth before application of this product
Description

Active ingredient Hydrocortisone 1%

Section 44425-7

Other information

  • Store at room temperature (do not freeze)
  • Tamper evident, do not use any opened or torn packets
Section 50565-1

Keep out of reach of  children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glycerol fatty acid ester, mineral oil, petrolactum, phenoxyethanol, water

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

  • for temorary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, posison 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
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 blotting with toilet tissue or a soft cloth before application of this product
Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching

When using this product:

  • Keep out of eyes, ears, and mouth
  • In case of contact with eyes, rinse eyes throughly with water

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 other hydrocortisone product unless you have consulted a doctor

bleeding occurs

Section 44425-7 (44425-7)

Other information

  • Store at room temperature (do not freeze)
  • Tamper evident, do not use any opened or torn packets
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 51727-6 (51727-6)

Inactive ingredients

cetearyl alcohol, ceteareth-20, ethylhexylglycerin, glycerin, glycerol fatty acid ester, mineral oil, petrolactum, phenoxyethanol, water

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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