Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID bf394192-c789-faff-e053-2995a90a52bc
Route
TOPICAL
Published
Effective Date 2021-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oatmeal (10 g)
Inactive Ingredients
Cocos Nucifera Whole Candelilla Wax Melaleuca Cajuputi Whole Eucalyptus Globulus Leaf .alpha.-tocopherol Acetate Menthol Methyl Salicylate Shea Butter Helianthus Annuus Whole Persea Americana Leaf Cymbopogon Schoenanthus Oil Arnica Montana Flower Elaeis Guineensis Whole Simmondsia Chinensis Whole Curcuma Longa Whole .beta.-bisabolol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-05

Description

Skin Protectant

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Skin Protectant

Uses

Temporarily protects and helps releive minor skin irritation and itching due to insect bites

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
Directions
  • Apply as needed.
Other Information

Store at 20-25C (68-77)F

Active Ingredients

Colloidal Oatmeal 10.00%

Inactive Ingredients

Cocos Nucifera Oil, Euphorbia Cerifera Wax, Caprylic/Capric Triglyceride, Melaleuca Cajuputi Oil, Eucalyptus Globulus Leaf Oil, Tocopheryl Acetate, Menthol, Methyl Salicylate, Butyrospermum Parkii Butter, Helianthus Annuus Seed Oil, Persea Gratissima Oil, Cymbopogon Schoenanthus Oil, Arnica Montana Flower Extract, Elaeis Guineensis Butter, Simmondsia Chinensis Seed Oil, Curcuma Longa Root Extract, Bisabolol

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 minor skin irritation and itching due to insect bites

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
Directions
  • Apply as needed.
Other Information

Store at 20-25C (68-77)F

Active Ingredients

Colloidal Oatmeal 10.00%

Inactive Ingredients

Cocos Nucifera Oil, Euphorbia Cerifera Wax, Caprylic/Capric Triglyceride, Melaleuca Cajuputi Oil, Eucalyptus Globulus Leaf Oil, Tocopheryl Acetate, Menthol, Methyl Salicylate, Butyrospermum Parkii Butter, Helianthus Annuus Seed Oil, Persea Gratissima Oil, Cymbopogon Schoenanthus Oil, Arnica Montana Flower Extract, Elaeis Guineensis Butter, Simmondsia Chinensis Seed Oil, Curcuma Longa Root Extract, Bisabolol

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

All Sections (JSON)