Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e728eb54-83e3-4318-af97-ee4804f7a7b8
Route
TOPICAL
Published
Effective Date 2019-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Cetostearyl Alcohol Sorbitan Monostearate Glycerin Cetyl Ethylhexanoate Glyceryl Monostearate Lactobacillus Reuteri Retinal, All-trans Bakuchiol Avocado Oil Centella Asiatica Whole Carrot Orange Oil Lavender Oil Litsea Oil Rosemary Oil Cananga Oil Xanthan Gum Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Phenoxyethanol Ethylhexylglycerin Phytate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-12-12

Description

Active Ingredient:  Salicylic Acid 2%


Medication Information

Warnings and Precautions

Warnings: For external use only.

Indications and Usage

Uses:

  • For the treatment of acne
  • Dries & clears acne blemishes and allow skin to heal.
  • Penetrates pores to reduce the number of blackheads and whiteheads.
  • Helps prevent new acne blemishes, whiteheads & blackheads from forming.
Dosage and Administration
  • Clean the skin thoroughly before applying this product.
  • 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 to three times 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:  Salicylic Acid 2%

Section 50565-1

Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Water (Aqua), Caprylic/Capric Triglyceride, Cetearyl Alcohol, Sorbitan Stearate, Glycerin, Cetyl Ethylhexanoate, Glyceryl Stearate, Lactobacillus Ferment, Retinal, Bakuchiol, Persea Gratissima (Avocado) Oil, Centella Asiatica Extract, Daucus Carota Sativa (Carrrot) Root Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Litsea Cubeba fruit Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Cananga Odorata Flower Oil, Xanthan Gum, Polyacrylate Crosspolymer-6, Phenoxyethanol, Ethylhexylglycerin, Sodium Phytate.

Section 51945-4

Kinship Inc.,

Corte Modera, CA 94925

Made In USA

lovekinship.com

Section 53413-1

Questions or comments?

Call toll free (877) 546-2582

Section 55105-1

Purpose: Acne Treatment

Section 55106-9

Active Ingredient: Salicylic Acid 2%

Section 60561-8

Other Information: Protect this product from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • For the treatment of acne
  • Dries & clears acne blemishes and allow skin to heal.
  • Penetrates pores to reduce the number of blackheads and whiteheads.
  • Helps prevent new acne blemishes, whiteheads & blackheads from forming.
Dosage and Administration (34068-7)
  • Clean the skin thoroughly before applying this product.
  • 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 to three times 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.

Section 50565-1 (50565-1)

Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Water (Aqua), Caprylic/Capric Triglyceride, Cetearyl Alcohol, Sorbitan Stearate, Glycerin, Cetyl Ethylhexanoate, Glyceryl Stearate, Lactobacillus Ferment, Retinal, Bakuchiol, Persea Gratissima (Avocado) Oil, Centella Asiatica Extract, Daucus Carota Sativa (Carrrot) Root Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Litsea Cubeba fruit Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Cananga Odorata Flower Oil, Xanthan Gum, Polyacrylate Crosspolymer-6, Phenoxyethanol, Ethylhexylglycerin, Sodium Phytate.

Section 51945-4 (51945-4)

Kinship Inc.,

Corte Modera, CA 94925

Made In USA

lovekinship.com

Section 53413-1 (53413-1)

Questions or comments?

Call toll free (877) 546-2582

Section 55105-1 (55105-1)

Purpose: Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient: Salicylic Acid 2%

Section 60561-8 (60561-8)

Other Information: Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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