Active Ingredient (In Each Gram)
Hydrocortisone 1.0%
Crane Safety Hydrocortisone
FDA Label NDC 73408-633
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Crane Safety Llc for the product Crane Safety Hydrocortisone (NDC 73408-633). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each gram), purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 59° to 86°F (15° to 30°C)
- 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 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®
* Please review the disclaimer below.
