ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3

SPL v2
SPL
SPL Set ID ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3
Route
topical
Published
Effective Date 2024-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (10 mg)
Inactive Ingredients
petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-01

Purpose

Anti-Itch 

Description

Hydrocortisone 1%


Medication Information

Uses

■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

■ eczema ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics

■ soaps ■ seborrheic dermatitis

■ temporarily relieves external anal and genital itching

■ other uses of this product should only be under the advice and supervision of a doctor

Purpose

Anti-Itch 

Description

Hydrocortisone 1%

Section 50565-1

Keep out of reach of children.

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

Drug Facts

Warnings 

For external use only 

Directions 

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 time daily
  • children under 2 years of age: ask a doctor

for external anal itching,

  • adults:when practical, clean the affected area with mild soap and warm water and rinse thoroughlygently dry by patting or blotting with toilet tissue or a soft cloth before applying

apply to affected area not more than 3 to 4 times daily

  • children under 12 years of age: ask a doctor
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.

Active Ingredient

Hydrocortisone 1%

Other Information 
  • Store at a controlled room temperature 20-25°C ( 68-77°F)
  • before using any medication read all label direction, keep carton it contains important information 
Inactive Ingredient 

Petrolatum 

Principal Display Panel 

CVS              NDC 51316-165-28    

Maximum strength

Cortisone Ointment 

Hydrocortisone 1%

NET WT 1.0 OZ  (28g)

When Using This Product 

■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly into the rectum by using fingers or any mechanical device or applicator

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


Structured Label Content

Uses

■ temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

■ eczema ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics

■ soaps ■ seborrheic dermatitis

■ temporarily relieves external anal and genital itching

■ other uses of this product should only be under the advice and supervision of a doctor

Purpose

Anti-Itch 

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Drug Facts

Warnings 

For external use only 

Directions 

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 time daily
  • children under 2 years of age: ask a doctor

for external anal itching,

  • adults:when practical, clean the affected area with mild soap and warm water and rinse thoroughlygently dry by patting or blotting with toilet tissue or a soft cloth before applying

apply to affected area not more than 3 to 4 times daily

  • children under 12 years of age: ask a doctor
Do Not Use  (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.

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information  (Other information )
  • Store at a controlled room temperature 20-25°C ( 68-77°F)
  • before using any medication read all label direction, keep carton it contains important information 
Inactive Ingredient  (Inactive ingredient )

Petrolatum 

Principal Display Panel 

CVS              NDC 51316-165-28    

Maximum strength

Cortisone Ointment 

Hydrocortisone 1%

NET WT 1.0 OZ  (28g)

When Using This Product  (When using this product )

■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly into the rectum by using fingers or any mechanical device or applicator

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


Advanced Ingredient Data


Raw Label Data

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