Skin-lube

Skin-lube
SPL v2
SPL
SPL Set ID d1005dec-04f6-3f88-e053-2a95a90ad9cb
Route
TOPICAL
Published
Effective Date 2021-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (850 mg) Dimethicone (15 mg)
Inactive Ingredients
Diazolidinyl Urea Methylparaben Propylene Glycol Propylparaben Zinc Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-01

Description

Petrolatum 85% Dimethicone 1.5%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Petrolatum 85% Dimethicone 1.5%

Uses

Temporarily protects minor • cuts • scrapes • burns – Helps prevent, temporarily protects, and helps relieve chafed, chapped or cracked skin. Helps prevent and protect from the drying effects of wind and cold weather.

Warnings

For external use only.

Directions

Apply as needed.

Questions?

(800) 345-2231

Do Not Use On

• deep or puncture wounds • animal bites • serious burns

Other Information

– Store in a cool dry place with lid closed tightly.

Active Ingredients

Petrolatum 85%

Dimethicone 1.5%

Inactive Ingredients

– Diazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Zinc Stearate

When Using This Product

do not get into eyes.

Stop Use and Ask A Doctor If

• condition worsens • symptoms last more than 7 days or clear up and occur again within a few days.

Package Labeling:82345 860 01

Package Labeling:82345 860 02

Package Labeling:82345 860 05

Package Labeling:82345 860 25

Keep Out of Reach of Children.

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


Structured Label Content

Uses

Temporarily protects minor • cuts • scrapes • burns – Helps prevent, temporarily protects, and helps relieve chafed, chapped or cracked skin. Helps prevent and protect from the drying effects of wind and cold weather.

Purpose

Skin Protectant

Warnings

For external use only.

Directions

Apply as needed.

Questions?

(800) 345-2231

Do Not Use On (Do not use on)

• deep or puncture wounds • animal bites • serious burns

Other Information

– Store in a cool dry place with lid closed tightly.

Active Ingredients

Petrolatum 85%

Dimethicone 1.5%

Inactive Ingredients

– Diazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Zinc Stearate

When Using This Product (When using this product)

do not get into eyes.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• condition worsens • symptoms last more than 7 days or clear up and occur again within a few days.

Package Labeling:82345 860 01 (Package Labeling:82345-860-01)

Package Labeling:82345 860 02 (Package Labeling:82345-860-02)

Package Labeling:82345 860 05 (Package Labeling:82345-860-05)

Package Labeling:82345 860 25 (Package Labeling:82345-860-25)

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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