Active Ingredient
White petrolatum 100% w/w
Petroleum Jelly
FDA Label NDC 87236-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldermed Inc. for the product Petroleum Jelly (NDC 87236-009). 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, uses, warnings, do not use on, when using this product, 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
- temporarily protects minor cuts, scrapes and burns
- helps prevent against the drying effects of wind and cols weather
- temporarily protects and chafed, chapped or cracked skin
- helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness
Warnings
For external use only
Do Not Use On
- deep or puncture wounds
- animal bites
- serious burns
When Using This Product
- do not get into eyes
Stop Use And Ask A Doctor If
- condition worsens
- symptoms last for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children.
In swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- As a skin protectant:apply as needed
- For diaper rash: Change wet and soiled diaper promptly, cleanse the diaper area, and allow to dry. Apply jelly liberally as often as necessary, with each diaper change, especially at bed-time or anytime when exposure to wet diapers may be prolonged.
Other Information
- store at room temperature 15-30 C (59-86F)
Inactive Ingredients
none
Questions Or Comments?
Monday-Friday 9AM-5PM CST
Distributror
Distributor:
ALDERMED INC.
7901 4TH ST N STE 300 ST PETERSBURG, FL 33702
www.aldermed.us MADE IN INDIA MH/DRUGS/25-KD/739
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