initial drug listing - aosorw folliculitis & acne treatment cream

initial drug listing - aosorw folliculitis & acne treatment cream
SPL v2
SPL
SPL Set ID 3a07f7dd-8159-46b1-e063-6294a90a774b
Route
topical
Published
Effective Date 2025-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (1 g)
Inactive Ingredients
butyrospermum parkii (shea) butter cetearyl glucoside avena sativa (oat) kernel oil glycerin aloe barbadensis leaf juice melaleuca alternifolia (tea tree) leaf oil water dimethicone ceramide np .alpha.-tocopherol acetate triethanolamine polyacrylate crosspolymer-6 dextrin, corn niacinamide dipotassium glycyrrhizate carbomer sophora flavescens root cocos nucifera (coconut) oil peg-100 stearate azelaic acid hydroxyacetophenone glyceryl stearate oldenlandia capensis whole allantoin panthenol cetearyl alcohol sodium acrylate propylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-07-30

Description

Salicylic Acid 1%


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Salicylic Acid 1%

Indications and Usage
  • For the treatment of acne
  • Helps prevent newacne blemishes
Dosage and Administration
  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to threetimes daily.
  • Because excessive drying of the skin may occur,start with one application daily, then gradually increase to two or three daily if needed or as directed by a doctor.
  • lf bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. lf no discomfort occurs, follow the directions stated elsewhere on this label.
Description

Salicylic Acid 1%

Section 50565-1

lf swallowed, get medical helpor contact the Poison Control Center right away

Section 50567-7
  • Skin irritation and dryness are morelikely to occur when using another topical acne product at thesame time. lf irritation occurs, use only one product at a time
  • Avoid eye area. In case of eye contact, flush gently and thoroughlywith water
Section 50569-3

lf you are under 2 years of age.

Section 51727-6

Water, Glycerin, Cetearyl Alcohol, Propylene Glycol,Dimethicone,Sophora Flavescens Extract, Butyrospermum, Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Oldenlandia Diffusa Extract, PEG-100 Stearate, Dextrin, 1,2-HexanediolAloe Barbadensis Leaf Juice, Hydroxyacetophenone, CetearylGlucoside, Glyceryl Stearate, Panthenol, Triethanolamine Polyacrylate Crosspolymer-6, Carbomer, Allantoin, Niacinamide.Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,Tocopheryl Acetate, Dipotassium Glycyrrhizate, Avena Sativa(Oat)Kernel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Azelaic Acid, Ceramide NP

Section 51945-4

Section 53413-1

Visit www.aosorw.com

Section 55105-1

Acne Treatment

Section 60561-8

Store at room temperature and out of direct sunlight. Keep the cap tightly closed after use。


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Salicylic Acid 1%

Indications and Usage (34067-9)
  • For the treatment of acne
  • Helps prevent newacne blemishes
Dosage and Administration (34068-7)
  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to threetimes daily.
  • Because excessive drying of the skin may occur,start with one application daily, then gradually increase to two or three daily if needed or as directed by a doctor.
  • lf bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. lf no discomfort occurs, follow the directions stated elsewhere on this label.
Section 50565-1 (50565-1)

lf swallowed, get medical helpor contact the Poison Control Center right away

Section 50567-7 (50567-7)
  • Skin irritation and dryness are morelikely to occur when using another topical acne product at thesame time. lf irritation occurs, use only one product at a time
  • Avoid eye area. In case of eye contact, flush gently and thoroughlywith water
Section 50569-3 (50569-3)

lf you are under 2 years of age.

Section 51727-6 (51727-6)

Water, Glycerin, Cetearyl Alcohol, Propylene Glycol,Dimethicone,Sophora Flavescens Extract, Butyrospermum, Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Oldenlandia Diffusa Extract, PEG-100 Stearate, Dextrin, 1,2-HexanediolAloe Barbadensis Leaf Juice, Hydroxyacetophenone, CetearylGlucoside, Glyceryl Stearate, Panthenol, Triethanolamine Polyacrylate Crosspolymer-6, Carbomer, Allantoin, Niacinamide.Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer,Tocopheryl Acetate, Dipotassium Glycyrrhizate, Avena Sativa(Oat)Kernel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Azelaic Acid, Ceramide NP

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Visit www.aosorw.com

Section 55105-1 (55105-1)

Acne Treatment

Section 60561-8 (60561-8)

Store at room temperature and out of direct sunlight. Keep the cap tightly closed after use。


Advanced Ingredient Data


Raw Label Data

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