FDA Label for White Petrolatum

View Indications, Usage & Precautions

White Petrolatum Product Label

The following document was submitted to the FDA by the labeler of this product Stratus Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts:

Distributed by: Stratus Pharmaceuticals Inc., Miami, FL 33186


Active Ingredient



White Petrolatum USP 100%


Purpose



Skin Protectant


Indications



For the temporary protection of minor cuts, scrapes, abrasions, burns, sunburns, chafed or chapped skin. Helps treat and prevent diaper rash.


Caution



In case of deep or puncture wounds or severe burns, consult a physician. If irritation, swelling or pain persists, or if infection occurs, discontinue use and consult a physician.

For external use only.


Warnings



Do not use in the eyes.

If swallowed, get medical help or contact a Poison Control Center immediately.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Directions



Cleanse area with mild soap and water.

Apply White Petrolatum liberally generously to affected area.


Other Information



Store at room temperature 15°C-30°C (59°F-86°F). Avoid excessive heat.


Description



White Petrolatum USP is a first aid ointment that protects and revitalizes chapped and cracked skin areas. It contains 100% White Petrolatum USP to help seal moisture into the skin. White Petrolatum USP Ointment can be applied to minor skin injuries including cuts, scrapes, rashes and burns. Each pouch contains a 5g unit dose individually sealed and barcoded.


Otc - Questions



Toll Free: 1-800-442-7882


Principal Display Panel - 5 G Packet Box



NDC: 58980-350-50

White Petrolatum USP
Ointment

Skin Protectant
Smooths skin irritations due to:
▪ minor burns   ▪ scrapes   ▪ abrasions

STRATUS
PHARMACEUTICALS INC

Contains:
144 packets / 5g each


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