SPL v1
SPL
SPL Set ID 13d11ae7-65b4-09f8-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (1.2 g) Glycerin
Inactive Ingredients
Water 1,3-butylene Glycol Calcium Sulfate Dihydrate Bassia Scoparia Fruit Hyaluronate Sodium Macadamia Seed Oil Glycereth-8 Esters Polyglyceryl-3 Dioleate Aloe Vera Leaf Squalene Urea

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-04-16

Description

Mineral Oil 1%, Glycerin 1%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Mineral Oil 1%, Glycerin 1%

Uses

To help the treatment of atopy, pruritus senilis, psoriasis and sensitive dermatitis.

Warning

For external use only. Do not swallow.

If you take any serious medications or medical condition, consult your doctor.

Direction

Apply to affected area twice daily, morning and evening. Gently massage onto damp skin after washing face or stepping out of the shower or bath.

Packaging

Other Information
  • Keep product out of direct sunlight, high temperature and humidity.
  • Store in a cool dry place.
  • Be careful not to get it in your eyes.
  • If rashes or skin irritation occurs, discontinue use.
  • Any items past the expiration date or damaged in transit can be exchanged where you originally purchased the item.
Active Ingredients

Mineral Oil 1%, Glycerin 1%

Inactive Ingredient

Purified Water, Butylene Glycol, Squalene, White Clay (terra alba), Urea, Kochia Scoparia Fruit Extract, Sodium Hyaluronate, Macadamia Seed Oil, Polyglyceryl-3, Methyl Glucose Dioleate, Aloe Vera Leaf Juice, Sorbitan Sterate, Dimethicone 6, Beewax, Camelia Oil, Simmondsia Chinensis (jojoba) Seed Oil, Centella Extract, Plantago Extract, Portulaca Extract, Japanese Angelica Root Extract, Trehalose, Malt Extract, Propolis Extract, Polyacrylamide, C13-14 Iosparaffin, Laureth-7, Salicylic Acid, Allantoin, Polyglutamic Acid, Methyl Paraben, Ceramide3, Phenoxyethanol, Propylparaben, Disodium EDTA, Fragrance.

Spl Unclassified Section

Do not exceed the recommended dosage.

To assure freshness and potency, store at room temperature 15 oC - 30 oC.

Store away from heat, light and moisture, if you are pregnant, nursing, taking any medication or have a medical condition, please consult your healthcare practitioner.

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Uses (USES)

To help the treatment of atopy, pruritus senilis, psoriasis and sensitive dermatitis.

Purpose (PURPOSE)

Skin Protectant

Warning (WARNING)

For external use only. Do not swallow.

If you take any serious medications or medical condition, consult your doctor.

Direction (DIRECTION)

Apply to affected area twice daily, morning and evening. Gently massage onto damp skin after washing face or stepping out of the shower or bath.

Packaging (PACKAGING)

Other Information (OTHER INFORMATION)
  • Keep product out of direct sunlight, high temperature and humidity.
  • Store in a cool dry place.
  • Be careful not to get it in your eyes.
  • If rashes or skin irritation occurs, discontinue use.
  • Any items past the expiration date or damaged in transit can be exchanged where you originally purchased the item.
Active Ingredients (ACTIVE INGREDIENTS)

Mineral Oil 1%, Glycerin 1%

Inactive Ingredient (INACTIVE INGREDIENT)

Purified Water, Butylene Glycol, Squalene, White Clay (terra alba), Urea, Kochia Scoparia Fruit Extract, Sodium Hyaluronate, Macadamia Seed Oil, Polyglyceryl-3, Methyl Glucose Dioleate, Aloe Vera Leaf Juice, Sorbitan Sterate, Dimethicone 6, Beewax, Camelia Oil, Simmondsia Chinensis (jojoba) Seed Oil, Centella Extract, Plantago Extract, Portulaca Extract, Japanese Angelica Root Extract, Trehalose, Malt Extract, Propolis Extract, Polyacrylamide, C13-14 Iosparaffin, Laureth-7, Salicylic Acid, Allantoin, Polyglutamic Acid, Methyl Paraben, Ceramide3, Phenoxyethanol, Propylparaben, Disodium EDTA, Fragrance.

Spl Unclassified Section (SPL UNCLASSIFIED SECTION)

Do not exceed the recommended dosage.

To assure freshness and potency, store at room temperature 15 oC - 30 oC.

Store away from heat, light and moisture, if you are pregnant, nursing, taking any medication or have a medical condition, please consult your healthcare practitioner.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)