at one with nature root revitalizer for dry itchy scalp

at one with nature root revitalizer for dry itchy scalp
SPL v1
SPL
SPL Set ID 206af367-45c3-4448-ab55-71bc9dcf785c
Route
topical
Published
Effective Date 2014-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (10 mg)
Inactive Ingredients
petrolatum sunflower oil castor oil salicylic acid high density polyethylene paraffin propylene glycol water calendula officinalis flower chamaemelum nobile flower tilia cordata flower centaurea cyanus flower chamomile hypericum perforatum olive oil sulfur sesame oil .alpha.-tocopherol acetate butylated hydroxytoluene propylparaben d&c green no. 6 d&c yellow no. 11

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2014-09-18

Purpose

Topical Analgesic

Description

Menthol 1.00%


Medication Information

Warnings
  • for external use only
Purpose

Topical Analgesic

Directions
  • Adult & children 2 year of age & older. Part hair into section & apply a dime size amount sparingly.
  • Massage into scalp to invigorate and insure absorption.
  • Apply to affected area not more then 3 to 4 times daily. Use daily for maximum results or flaking & itching has stopped.
  • Children under 2 years of age ask a doctor
Inactive Ingredients

Petrolatum, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Salicylic Acid, Polyethylene, Paraffin, Propylene Glycol, Water, Calendula Officinalis (Pot Marigold ) Flower Extract, Anthemis Nobilis Chamomile Flower Extract , Tilia Cordata (Linden)Flower Extract, Centaurea Cyanus (Cornflower) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Hypericum Perforatum Extract (St. John's Wort) Extract, Fragrance, Olea Europaea (Olive) Fruit Oil, Sulfur, Sesame (Sesamum Indicum) Oil, Tocopheryl Acetate, BHT, Propylparaben, Green 6, Yellow 11

Description

Menthol 1.00%

Principal Display Panel

biocare5oz

Use

temporary relief of itching associated with scalp irritation.

Active Ingredient

Menthol 1.00%

When Using This Product
  • avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If
  • condition worsens, or if symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days.
  • excessive skin irritation

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Warnings (WARNINGS)
  • for external use only
Purpose (PURPOSE)

Topical Analgesic

Directions
  • Adult & children 2 year of age & older. Part hair into section & apply a dime size amount sparingly.
  • Massage into scalp to invigorate and insure absorption.
  • Apply to affected area not more then 3 to 4 times daily. Use daily for maximum results or flaking & itching has stopped.
  • Children under 2 years of age ask a doctor
Inactive Ingredients (INACTIVE INGREDIENTS)

Petrolatum, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Salicylic Acid, Polyethylene, Paraffin, Propylene Glycol, Water, Calendula Officinalis (Pot Marigold ) Flower Extract, Anthemis Nobilis Chamomile Flower Extract , Tilia Cordata (Linden)Flower Extract, Centaurea Cyanus (Cornflower) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Hypericum Perforatum Extract (St. John's Wort) Extract, Fragrance, Olea Europaea (Olive) Fruit Oil, Sulfur, Sesame (Sesamum Indicum) Oil, Tocopheryl Acetate, BHT, Propylparaben, Green 6, Yellow 11

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

biocare5oz

Use (USE)

temporary relief of itching associated with scalp irritation.

Active Ingredient (ACTIVE INGREDIENT)

Menthol 1.00%

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, or if symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days.
  • excessive skin irritation

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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