CRANE SAFETY HYDROCORTISONE- hydrocortisone cream 
Crane Safety LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Crane Safety Hydrocortisone Cream

Drug Facts

Active ingredient (in each gram)

Hydrocortisone 1.0%

Purpose

Antipruritic (Anti-itch)

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

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

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.

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

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

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®

Crane

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 S

CRANE SAFETY HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-933(NDC:47682-933)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73408-933-7325 in 1 BOX01/17/2020
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/17/2020
CRANE SAFETY HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-633(NDC:47682-633)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73408-633-7325 in 1 BOX01/17/2020
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/17/2020
Labeler - Crane Safety LLC (080998015)
Registrant - Unifirst First Aid Corporation (832947092)
Establishment
NameAddressID/FEIBusiness Operations
Medique Products086911794relabel(73408-933, 73408-633) , repack(73408-933, 73408-633)

Revised: 12/2019
 
Crane Safety LLC