drug facts

drug facts
SPL v5
SPL
SPL Set ID df95a616-714e-4727-af91-1b993a55b661
Route
topical
Published
Effective Date 2020-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (3 g)
Inactive Ingredients
lanolin petrolatum water zinc oxide starch, corn grape seed oil cannabis sativa seed oil calendula officinalis flower chamaemelum nobile flower oil evening primrose oil white wax polysorbate 65 polysorbate 80 silybum marianum seed oil phenoxyethanol vitamin a vitamin d borage seed oil almond oil levomenol nigella sativa seed oil lavender oil

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2014-05-05

Purpose

Psoriasis and Seborrheic Dermatitis

Description

Salicylic acid 3%


Medication Information

Warnings

For external use only.

Uses

Relieves and helps prevent symptomatic recurrence of the skin:



  • Itching
  • Irritation
  • Redness
  • Flaking
  • Scaling
  • Dryness

Purpose

Psoriasis and Seborrheic Dermatitis

Directions

Apply to the affected areas two to four times daily or as directed by a medical doctor.

Other Information

Keep carton for full drug facts.

Inactive Ingredients

anthemis nobilis flower oil, beeswax, bisabolol, borago officianalis seed oil, calamine, calendula officinalis flower oil, cannabis sativa seed oil, lanolin, lavandula angustifolia oil, linum usitatissimum seed oil, nigella sativa seed oil, oenothera biennis (evening primrose) oil, petrolatum, phenoxyetahnol,

polysorbate 80, prunus amygdalus dulcis (sweet almond) oil, retinyl palmitate (vitamin A), silybum marinum seed oil, sorbitan tristearate, tocopheryl

acetate (vitamin E), vitis vinifera (grape) seed oil, water, zea mays (corn) starch, zinc oxide.

Description

Salicylic acid 3%

Principal Display Panel

NDC: 63302-202-02

DermaZor Psoriasis

MEDICATED SKIN TREATMENT

Psoriasis and Seborrheic Dermatitis Cream

Hypoallergenic No Side Effects

Relieves and helps prevent Symptomatic recurrences:

  • Itching
  • Irritation
  • Redness
  • Flaking
  • Scaling
  • Dryness

A Patented Unique Formula

3% Salicylic Acid, Zinc and Cannabis Oil Complex

Non-Steroidal, Non-Coal Tar

FL OZ | 100 ml 3.5

Section 42229-5

Distributed by: DISTR.MED.LLC USA

Stirling RD Davie, Florida 33024 | T 754.816.5411



Made in Israel | www.DermaZor.com

FDA OTC Listed | NDC #63302-202-02

Side Effects

DermaZor has no side effects. If you are allergic to any of the ingredients in the cream, do not use.

Active Ingredients

Salicylic acid 3%

Questions Or Comments:

[email protected]

Website: www.DermaZor.com

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 does not improve after regular use as directed.

Keep Out of Reach of Children

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


Structured Label Content

Warnings

For external use only.

Uses

Relieves and helps prevent symptomatic recurrence of the skin:



  • Itching
  • Irritation
  • Redness
  • Flaking
  • Scaling
  • Dryness

Purpose

Psoriasis and Seborrheic Dermatitis

Directions

Apply to the affected areas two to four times daily or as directed by a medical doctor.

Other Information

Keep carton for full drug facts.

Inactive Ingredients

anthemis nobilis flower oil, beeswax, bisabolol, borago officianalis seed oil, calamine, calendula officinalis flower oil, cannabis sativa seed oil, lanolin, lavandula angustifolia oil, linum usitatissimum seed oil, nigella sativa seed oil, oenothera biennis (evening primrose) oil, petrolatum, phenoxyetahnol,

polysorbate 80, prunus amygdalus dulcis (sweet almond) oil, retinyl palmitate (vitamin A), silybum marinum seed oil, sorbitan tristearate, tocopheryl

acetate (vitamin E), vitis vinifera (grape) seed oil, water, zea mays (corn) starch, zinc oxide.

Principal Display Panel

NDC: 63302-202-02

DermaZor Psoriasis

MEDICATED SKIN TREATMENT

Psoriasis and Seborrheic Dermatitis Cream

Hypoallergenic No Side Effects

Relieves and helps prevent Symptomatic recurrences:

  • Itching
  • Irritation
  • Redness
  • Flaking
  • Scaling
  • Dryness

A Patented Unique Formula

3% Salicylic Acid, Zinc and Cannabis Oil Complex

Non-Steroidal, Non-Coal Tar

FL OZ | 100 ml 3.5

Section 42229-5 (42229-5)

Distributed by: DISTR.MED.LLC USA

Stirling RD Davie, Florida 33024 | T 754.816.5411



Made in Israel | www.DermaZor.com

FDA OTC Listed | NDC #63302-202-02

Side Effects (Side effects)

DermaZor has no side effects. If you are allergic to any of the ingredients in the cream, do not use.

Active Ingredients

Salicylic acid 3%

Questions Or Comments: (Questions or Comments:)

[email protected]

Website: www.DermaZor.com

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 does not improve after regular use as directed.

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

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


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