clinical Emergency Zit Stick

 clinical Emergency Zit Stick
SPL v4
SPL
SPL Set ID 6308364b-4f8c-4a26-bf6a-6b54c3c2402f
Route
TOPICAL
Published
Effective Date 2013-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Butylene Glycol Cetostearyl Alcohol Cetyl Alcohol Glycerin Steareth-2 Oleth-10 Medium-chain Triglycerides Octyldodecanol Caprylyl Trisiloxane Bakuchiol Allantoin Hyaluronate Sodium Dihexadecyl Phosphate C18-c21 Alkane Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Caprylyl Glycol Xanthan Gum Squalane Ethylhexylglycerin Polysorbate 60 Polyisobutylene (1300 Mw) Ceteth-10 Phosphate Edetate Disodium Levomenol Phenoxyethanol Sodium Hydroxide Magnesium Aluminum Silicate .alpha.-tocopherol Acetate Sodium Benzoate Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-11-05

Description

Active ingredient             Purpose Salicylic Acid 2%           Acne Treatment Cream


Medication Information

Warnings and Precautions

Warnings

For external use only

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. if this occurs only one medication should be used unless directed by a physician.

Apply to effected areas only

Indications and Usage

Do not use:

on broken skin

on apply to large areas of the body

Dosage and Administration

Directions

Cleanse the skin thoroughly before applying this medication.

Cover the entire affected area with a thin layer one to three times daily.

Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three time daily if needed or as directed by a doctor.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Description

Active ingredient             Purpose Salicylic Acid 2%           Acne Treatment Cream

Section 50565-1

Keep out of reach of children. If swallowed get medical or contact a Poison Control Center right away. If swallowed get medical help or contact a poison control center right away.

Section 51727-6

Inactive ingredients

Water (Aqua), Butylene Glycol, Cetearyl Alcohol, Cetyl Alcohol, Glycerin, Caprylic/Capric Triglyceride, Steareth-2, Oleth-10, Octyldodecanol, Caprylyl Methicone, Bakuchiol, Allantoin, Bisabolol, Boerhavia Diffusia Root Extract, C18-21 Alkane, Caprylyl Glycol, Ceteth-10 Phosphate, Dicetyl Phophate, Disodium EDTA, Ethylhexylglycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Hydrolyzed Optunia Ficus-Indica Flower Extract, Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer, Magnesium Aluminum Silicate, Phenoxyethanol, Polyisobutene, Polysorbate 60, PVM/MA Copolymer, Sodium Benzoate, Sodium Hyaluronate, Sodium Hydroxide, Squalane, Titanium Dioxide (CI 77891), Tocopheryl Acetate, Xanthan Gum.

Section 51945-4

Emergency Zit StickTM

Acne Treatment

" I always keep one in my purse"

.07 fl.oz. [2 ml]

Section 55105-1

Uses

Treats acne

Clears up acne blemishes

Penetrates Pores to clear most acne pimples

Section 55106-9

Active ingredient             Purpose

Salicylic Acid 2%           Acne Treatment Cream


Structured Label Content

Indications and Usage (34067-9)

Do not use:

on broken skin

on apply to large areas of the body

Dosage and Administration (34068-7)

Directions

Cleanse the skin thoroughly before applying this medication.

Cover the entire affected area with a thin layer one to three times daily.

Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three time daily if needed or as directed by a doctor.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Warnings and Precautions (34071-1)

Warnings

For external use only

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. if this occurs only one medication should be used unless directed by a physician.

Apply to effected areas only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical or contact a Poison Control Center right away. If swallowed get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Inactive ingredients

Water (Aqua), Butylene Glycol, Cetearyl Alcohol, Cetyl Alcohol, Glycerin, Caprylic/Capric Triglyceride, Steareth-2, Oleth-10, Octyldodecanol, Caprylyl Methicone, Bakuchiol, Allantoin, Bisabolol, Boerhavia Diffusia Root Extract, C18-21 Alkane, Caprylyl Glycol, Ceteth-10 Phosphate, Dicetyl Phophate, Disodium EDTA, Ethylhexylglycerin, Glyceryl Acrylate/Acrylic Acid Copolymer, Hydrolyzed Optunia Ficus-Indica Flower Extract, Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer, Magnesium Aluminum Silicate, Phenoxyethanol, Polyisobutene, Polysorbate 60, PVM/MA Copolymer, Sodium Benzoate, Sodium Hyaluronate, Sodium Hydroxide, Squalane, Titanium Dioxide (CI 77891), Tocopheryl Acetate, Xanthan Gum.

Section 51945-4 (51945-4)

Emergency Zit StickTM

Acne Treatment

" I always keep one in my purse"

.07 fl.oz. [2 ml]

Section 55105-1 (55105-1)

Uses

Treats acne

Clears up acne blemishes

Penetrates Pores to clear most acne pimples

Section 55106-9 (55106-9)

Active ingredient             Purpose

Salicylic Acid 2%           Acne Treatment Cream


Advanced Ingredient Data


Raw Label Data

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