Curology - Barrier Balm (82575-302)

Curology - Barrier Balm (82575-302)
SPL v6
SPL
SPL Set ID 04b2ba38-0f81-be51-e063-6294a90af821
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
.alpha.-tocopherol Acetate, Dl- Shea Butter Water Polyhydroxystearic Acid (2300 Mw) Triethoxycaprylylsilane Synthetic Wax (1800 Mw) Zinc Oxide Butylated Hydroxytoluene Medium-chain Triglycerides Aluminum Starch Octenylsuccinate

Identifiers & Packaging

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

Description

Dimethicone 13% Petrolatum 41.9%


Medication Information

Warnings and Precautions

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

Uses

  • 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

For External Use Only

Apply as needed

Dosage and Administration

Directions

Apply as needed

Description

Dimethicone 13% Petrolatum 41.9%

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, Water, Zinc Oxide, Tocopheryl Acetate, Sodium Hyaluronate, Triethoxycaprylylsilane, BHT.

Section 51945-4

Section 53413-1

Questions?

858-859-1188

Section 55105-1

Skin Protectant

Section 55106-9

Dimethicone 13%

Petrolatum 41.9%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • 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

For External Use Only

Apply as needed

Dosage and Administration (34068-7)

Directions

Apply as needed

Warnings and Precautions (34071-1)

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, Water, Zinc Oxide, Tocopheryl Acetate, Sodium Hyaluronate, Triethoxycaprylylsilane, BHT.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

858-859-1188

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Dimethicone 13%

Petrolatum 41.9%


Advanced Ingredient Data


Raw Label Data

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