Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1a863cea-69b7-49b4-95c6-8f4a8faa8294
Route
TOPICAL
Published
Effective Date 2012-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (41.0 g)
Inactive Ingredients
Mineral Oil Ceresin Lanolin Alcohols Panthenol Glycerin .alpha.-bisabolol, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-01-03

Description

PETROLATUM 41%

Purpose

SKIN PROTECTANT


Medication Information

Purpose

SKIN PROTECTANT

Description

PETROLATUM 41%

Uses

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

Warnings

FOR EXTERNAL USE ONLY.

Directions

APPLY AS NEEDED.

Do Not Use

ON DEEP OR PUNCTURE WOUNDS, INFECTIONS OR LACERATIONS.

Label Copy

Questions?

CALL 1-800-910-6874.

Active Ingredient

PETROLATUM 41%

Other Information

STORE AT ROOM TEMPERATURE.

Inactive Ingredients:

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

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

Keep Out of Reach of Children

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

Stop Using This Product and Ask A Doctor If

CONDITION WORSENS OR SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.


Structured Label Content

Uses (USES)

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

Purpose (PURPOSE)

SKIN PROTECTANT

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)

APPLY AS NEEDED.

Do Not Use (DO NOT USE)

ON DEEP OR PUNCTURE WOUNDS, INFECTIONS OR LACERATIONS.

Label Copy (LABEL COPY)

Questions? (QUESTIONS?)

CALL 1-800-910-6874.

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)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE 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 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 LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.


Advanced Ingredient Data


Raw Label Data

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