Skin Barrier Balm

Skin Barrier Balm
SPL v1
SPL
SPL Set ID 01df9746-991b-4363-e063-6294a90aaac6
Route
TOPICAL
Published
Effective Date 2023-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone 20 (13 g) Petrolatum (41.9 g)
Inactive Ingredients
Polyhydroxystearic Acid (2300 Mw) Zinc Oxide .alpha.-tocopherol Acetate, Dl- Synthetic Wax (1800 Mw) Water Butylated Hydroxytoluene Medium-chain Triglycerides Shea Butter Aluminum Starch Octenylsuccinate Triethoxycaprylylsilane Hyaluronate Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-02

Description

Active Ingredient Petrolatum 41.9% Dimethicone 13.0%


Medication Information

Warnings and Precautions

Warnings

For external use only

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

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 doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

Indications and Usage

Directions

Apply as needed

Dosage and Administration

Apply as needed

Description

Active Ingredient Petrolatum 41.9% Dimethicone 13.0%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6

Caprylic/Capric triglyceride, Butyrospermum Parkii (Shea Butter), Aluminum Starch Octenylsuccinate, Synthetic Wax, Polyhydroxystearic Acid, Sodium Hyaluronate, Water, Zinc Oxide, Tocopheryl Acetate, Triethoxycaprylylsilane

Section 51945-4

Section 53413-1

Questions?

858-859-1188

Section 55105-1

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

Temporarily protects minor cuts, scrapes, burns

Section 55106-9

Active Ingredient

Petrolatum 41.9%

Dimethicone 13.0%


Structured Label Content

Indications and Usage (34067-9)

Directions

Apply as needed

Dosage and Administration (34068-7)

Apply as needed

Warnings and Precautions (34071-1)

Warnings

For external use only

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

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 doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

Caprylic/Capric triglyceride, Butyrospermum Parkii (Shea Butter), Aluminum Starch Octenylsuccinate, Synthetic Wax, Polyhydroxystearic Acid, Sodium Hyaluronate, Water, Zinc Oxide, Tocopheryl Acetate, Triethoxycaprylylsilane

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

858-859-1188

Section 55105-1 (55105-1)

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

Temporarily protects minor cuts, scrapes, burns

Section 55106-9 (55106-9)

Active Ingredient

Petrolatum 41.9%

Dimethicone 13.0%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)