Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 2bf0931e-245d-14a6-e063-6294a90a6681
Route
TOPICAL
Published
Effective Date 2023-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (45 g)
Inactive Ingredients
Mineral Oil Dimethicone Hexyldecanol Ceresin Rapeseed Sterol Rosemary Stearic Acid Sunflower Seed Tocopherol 1,2-hexanediol Brassica Rapa Subsp. Oleifera Oil Levomenol Cetylhydroxyproline Palmitamide Rice Bran

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-17

Description

Skin Protectant

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Skin Protectant

Uses

•Temporarily protects and helps releive chafed, chapped or craked skin and lips

•Temporarily protects minor:

   •cuts

   •scrapes

   •burns

•Helps protect form the drying effects of wind and cold weather

Warnings

Fox external use only.

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. Do not use on • deep or puncture woulds • animal bites • serious burns.
Directions

Apply as needed.

Other Information

Visit prequelskin.com

Active Ingredients

Petrolatum 45.00%

Inactive Ingredients

Parrafinum Liquidum, Ozokerite, Dimethicone, Brassica Campestric/Aleuites Fordi Oil Copolymer, Bisabolol, Cetylhydroxyproline Palmitamide, Oryza Sativa Bran Extract, Helianthus Annuus Extract, Tocopherol, Rosmarinus Officinalis Leaf Extract, Stearic Acid, Brassica Campestris Sterols, 1,2-Hexanediol, Hexyldecanol

Principal Display Panel

Keep Out of Reach of Children. If Swalled, Get Medical Help Or Contact A Poison Control Center Right Away.

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


Structured Label Content

Uses

•Temporarily protects and helps releive chafed, chapped or craked skin and lips

•Temporarily protects minor:

   •cuts

   •scrapes

   •burns

•Helps protect form the drying effects of wind and cold weather

Purpose

Skin Protectant

Warnings

Fox external use only.

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. Do not use on • deep or puncture woulds • animal bites • serious burns.
Directions

Apply as needed.

Other Information

Visit prequelskin.com

Active Ingredients

Petrolatum 45.00%

Inactive Ingredients

Parrafinum Liquidum, Ozokerite, Dimethicone, Brassica Campestric/Aleuites Fordi Oil Copolymer, Bisabolol, Cetylhydroxyproline Palmitamide, Oryza Sativa Bran Extract, Helianthus Annuus Extract, Tocopherol, Rosmarinus Officinalis Leaf Extract, Stearic Acid, Brassica Campestris Sterols, 1,2-Hexanediol, Hexyldecanol

Principal Display Panel

Keep Out of Reach of Children. If Swalled, Get Medical Help Or Contact A Poison Control Center Right Away. (Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.)

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


Advanced Ingredient Data


Raw Label Data

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