Crane Safety Hydrocortisone Cream

Crane Safety Hydrocortisone Cream
SPL v7
SPL
SPL Set ID 96d9527d-9bf7-ce82-e053-2995a90aff0c
Route
TOPICAL
Published
Effective Date 2019-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Propylparaben Mineral Oil Petrolatum Water Alcohol Methylparaben Paraffin White Wax Polysorbate 80 Titanium Dioxide Phenoxyethanol Citric Acid Monohydrate Glyceryl Monostearate Chlorphenesin Benzoic Acid Glycerin Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-17 Until 2024-12-01

Description

Hydrocortisone 1.0%

Purpose

Antipruritic (Anti-itch)


Medication Information

Purpose

Antipruritic (Anti-itch)

Description

Hydrocortisone 1.0%

Uses
  • for the temporary relief of itching associated with minor skin irritation, inflammation and rashes
  • for externalgenital,femine and anal itching
  • other uses for this product should be only under the advice and supervision of a doctor
Warnings

For external use only

Directions

Adults and children 2 years of age and over:

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

Children under 2 years:

do not use and ask a doctor

For external genital itching in adults:

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

Children under 12 years of age:

ask a doctor

Do Not Use

  • for the teatment of diaper rash
  • with any other hydrocortisone product unless you have consulted a doctor
  • if you have vaginal discharge, consult a doctor
Other Information
  • store at room temperature 59º to 86ºF (15º to 30ºC)
  • tamper evident, do not use if packet is toen, cut or opened
  • avoid excessive heat and humidity
Inactive Ingredients

benzoic acid*, chlorphenesin*, citric acid*, emulsifying wax*, ethyl alcohol*, glycerin*, glycerol monostearate*, methylparaben, mineral oil, paraffin*, petrolatum, phenoxyethanol*, polysorbate 80*, propylparaben*, purified water, titanium dioxide*, trisodium citrate*, white wax*

May contain*

Questions Or Comments?

877.506.4291

Stop Use and Ask A Doctor If
  • condition worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product
  • rectal bleeding occurs
Keep Out of Reach of Children.

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

Active Ingredient (in Each Gram)

Hydrocortisone 1.0%

Crane Safety Hydrocortisone Label

Hydrocortisone Cream 1%

Temporary Relief of Itching Associated With Minor Skin Irritation and Rashes

Product CS93373

0.9 g (1/32 oz) Packets

25/Box

CRANE Safety®

Crane Safety Hydrocortisone 1% Cream Label

Hydrocortisone Cream 1%

Temporary Relief of Itching Associated With Minor Skin Irritation and Rashes

Product CS93373

0.9 g (1/32 oz) Packets

25/Box

CRANE Safety®


Structured Label Content

Uses
  • for the temporary relief of itching associated with minor skin irritation, inflammation and rashes
  • for externalgenital,femine and anal itching
  • other uses for this product should be only under the advice and supervision of a doctor
Purpose

Antipruritic (Anti-itch)

Warnings

For external use only

Directions

Adults and children 2 years of age and over:

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

Children under 2 years:

do not use and ask a doctor

For external genital itching in adults:

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

Children under 12 years of age:

ask a doctor

Do Not Use (Do not use)

  • for the teatment of diaper rash
  • with any other hydrocortisone product unless you have consulted a doctor
  • if you have vaginal discharge, consult a doctor
Other Information (Other information)
  • store at room temperature 59º to 86ºF (15º to 30ºC)
  • tamper evident, do not use if packet is toen, cut or opened
  • avoid excessive heat and humidity
Inactive Ingredients (Inactive ingredients)

benzoic acid*, chlorphenesin*, citric acid*, emulsifying wax*, ethyl alcohol*, glycerin*, glycerol monostearate*, methylparaben, mineral oil, paraffin*, petrolatum, phenoxyethanol*, polysorbate 80*, propylparaben*, purified water, titanium dioxide*, trisodium citrate*, white wax*

May contain*

Questions Or Comments? (Questions or comments?)

877.506.4291

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product
  • rectal bleeding occurs
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Gram) (Active ingredient (in each gram))

Hydrocortisone 1.0%

Crane Safety Hydrocortisone Label

Hydrocortisone Cream 1%

Temporary Relief of Itching Associated With Minor Skin Irritation and Rashes

Product CS93373

0.9 g (1/32 oz) Packets

25/Box

CRANE Safety®

Crane Safety Hydrocortisone 1% Cream Label

Hydrocortisone Cream 1%

Temporary Relief of Itching Associated With Minor Skin Irritation and Rashes

Product CS93373

0.9 g (1/32 oz) Packets

25/Box

CRANE Safety®


Advanced Ingredient Data


Raw Label Data

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