Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID cbe10b90-354e-4396-b878-cff31a4b0e2e
Route
TOPICAL
Published
Effective Date 2012-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (410 mg)
Inactive Ingredients
Mineral Oil Ceresin Lanolin Alcohols Panthenol Glycerin Levomenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-10-15

Description

PETROLATUM 41%

Purpose

SKIN PROTECTANT


Medication Information

Purpose

SKIN PROTECTANT

Description

PETROLATUM 41%

Uses

TEMPORARILY PROTECTS MINOR CUTS, SCRAPES, BURNS. TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED OR CRACKED SKIN AND LIPS. HELPS PROTECT FOM THE DRYING EFFECTS OF COLD WIND AND WEATHER.

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY

Directions

APPLY AS NEEDED.

Active Ingredient

PETROLATUM 41%

Other Information

STORE AT ROOM TEMPERATURE.

Inactive Ingredients

MINERAL OIL, CERESIN, LANOLIN ALCOHOL, PANTHENOL, GLYCERIN, BISABOLOL.

When Using This Product

DO NOT GET INTO EYES. IF CONTACT OCCURS, WINSE THOROUGHLY WITH WATER.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask A Doctor If

CONDITION WORSENS OR SYMPTOMS PERSIST MORE THAN SEVEN DAYS OR CLEAR UP AND RECUR WITHIN A FEW DAYS. DO NOT USE ON DEEP OR PUNCTURE WOUNDS, ON ANIMAL BITES OR ON SERIOUS BURNS.


Structured Label Content

Uses (USES)

TEMPORARILY PROTECTS MINOR CUTS, SCRAPES, BURNS. TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED OR CRACKED SKIN AND LIPS. HELPS PROTECT FOM THE DRYING EFFECTS OF COLD WIND AND WEATHER.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

SKIN PROTECTANT

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Directions (DIRECTIONS)

APPLY AS NEEDED.

Active Ingredient (ACTIVE INGREDIENT)

PETROLATUM 41%

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE.

Inactive Ingredients (INACTIVE INGREDIENTS)

MINERAL OIL, CERESIN, LANOLIN ALCOHOL, PANTHENOL, GLYCERIN, BISABOLOL.

When Using This Product (WHEN USING THIS PRODUCT)

DO NOT GET INTO EYES. IF CONTACT OCCURS, WINSE THOROUGHLY WITH WATER.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

CONDITION WORSENS OR SYMPTOMS PERSIST MORE THAN SEVEN DAYS OR CLEAR UP AND RECUR WITHIN A FEW DAYS. DO NOT USE ON DEEP OR PUNCTURE WOUNDS, ON ANIMAL BITES OR ON SERIOUS BURNS.


Advanced Ingredient Data


Raw Label Data

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