Active Ingredient (In Each Gram)
White Petrolatum, USP, 100% w/w
Astonea Petrolatum
FDA Label NDC 77338-211
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Astonea Labs Private Limited for the product Astonea Petrolatum (NDC 77338-211). 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, directions, warnings, do not use on, stop use and ask a doctor if, 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
Skin Protectant
Uses
- Helps treat and prevent diaper rash
- Helps seal out wetness
- Temporarily protects minor cuts, scrapes and burns
- Temporarily helps protect and helps relieve chapped and cracked skin or lips
- Helps prevent and protect from the drying effects of wind and cold weather
- Helps prevent and protect from chafed skin or mionr skin irritations associated with diaper rash, with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged
Directions
- Change wet and soiled diapers promptly
- Cleanse the diaper area and allow to dry
- Apply as needed
Warnings
For External Use Only.
Do Not Use On
- Deep or puncture wounds
- Animal bites
- Serious burns
Stop Use And Ask A Doctor If
- The condition persists or gets worse
- Symptoms persists for more than 7 days or clear up and occur again within a few days.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Other Information
- Store at controlled room temperature 15 o - 30 oC(59 o--86 o F)
- Avoid excessive heat and humidity
- Tamper evident
- Do not use if packet is torn, cut or opened
When Using This Product
- Do not get into eyes
Inactive Ingredients
None
* Please review the disclaimer below.
