Active Ingredient
Hydrocortisone 1%
Roosin
FDA Label NDC 81552-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roosin Medical Co., Ltd for the product Roosin (NDC 81552-003). 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, purpose, use, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Itch
Use
Temporary relieves itching associated with minor irritations and rashes
Other uses should be only under the advice and supervision of a doctor
Warnings
For external use only
Otc - Do Not Use
Do not use
- In or near eyes
- For diaper rash, consult a doctor
Otc - When Using
When using this product
- Do not use any other hydrocortisone products unless you have contacted a doctor
Otc - Stop Use
Stop use and ask a doctor if
Condition worsens or persists for more than 7 days
Symptoms clear up and occur within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If ingested, get medical help or contact a poison control center right away
Directions
Adults and children two years of age and older: Apply to affected area not more than 3-4 timesdaily
Children under 2 years of age: Do not use
Inactive Ingredients
Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water
Other Information
Store at room temperature
Package Label.Principal Display Panel
Image Description (20210416 04)
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