Acne Spot Treatment

Acne Spot Treatment
SPL v3
SPL
SPL Set ID f7fd3f24-7c27-b45b-e053-6394a90a50ae
Route
TOPICAL
Published
Effective Date 2023-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Artemisia Vulgaris Root Manuka Oil Magnolia Officinalis Bark Magnolia Grandiflora Bark Hydroxyacetophenone Sodium Hydroxide Fu Ling Propanediol Chlorella Vulgaris Helichrysum Italicum Flower White Pepper Limosilactobacillus Fermentum Propylene Glycol Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Sodium Chloride Dicaprylyl Ether Water Oat Aloe Vera Leaf Saccharide Isomerate 1,2-hexanediol Soybean Oil Laminaria Digitata Lauryl Alcohol Octyldodecanol Glycerin Tetrasodium Glutamate Diacetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-27

Description

Active Ingredients: Salicylic Acid 2% Purpose: Acne medication


Medication Information

Warnings and Precautions

Warning: For external use only

Indications and Usage

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.

Dosage and Administration

Directions:

  • 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 or three times daily or as directed by a doctor
  • If bothersome dryness or peeling occurs reduce application to once a day or every other day
Description

Active Ingredients: Salicylic Acid 2% Purpose: Acne medication

Section 50565-1

Keep out of reach of children. If swallowed, get medical help ro contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients: Water, Propanediol, Lactobacillus Ferment, Pentylene Glycol, Polyacrylate Crosspolymer-6, Octyldodecanol, Glycerin, 1,2-Hexanediol, Glycine Soja (Soybean) Oil, Laminaria Digitata Extract, Sodium Hydroxide, Artemisia Vulgaris Extract, Hydroxyacetophenone, Sea Water, Tetrasodium Glutamate Diacetate, Leptospermum Scoparium Branch/Leaf Oil, Magnolia Officinalis Bark Extract, Piper Nigrum (Pepper) Seed Extract, Chlorella Vulgaris Extract, Dicaprylyl Ether, Phragmites Kharka Extract, Poria Cocos Extract, Lauryl Alcohol, Magnolia Grandiflora Bark Extract, Saccharide Isomerate, Aloe Barbadensis Leaf Juice, Helichrysum Italicum Extract, Avena Sativa (Oat) Kernel Extract

Section 51945-4

DIME

ACNE SPOT TREATMENT

SALICYLIC ACID + PROBIOTICS

0.5 FL OZ | 15 ML

Section 55105-1

Uses: For the treatment of acne

Section 55106-9

Active Ingredients: Salicylic Acid 2%

Purpose: Acne medication

Section 60561-8

Questions?

(801) 996-8274

[email protected]


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

Directions:

  • 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 or three times daily 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)

Warning: For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help ro contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients: Water, Propanediol, Lactobacillus Ferment, Pentylene Glycol, Polyacrylate Crosspolymer-6, Octyldodecanol, Glycerin, 1,2-Hexanediol, Glycine Soja (Soybean) Oil, Laminaria Digitata Extract, Sodium Hydroxide, Artemisia Vulgaris Extract, Hydroxyacetophenone, Sea Water, Tetrasodium Glutamate Diacetate, Leptospermum Scoparium Branch/Leaf Oil, Magnolia Officinalis Bark Extract, Piper Nigrum (Pepper) Seed Extract, Chlorella Vulgaris Extract, Dicaprylyl Ether, Phragmites Kharka Extract, Poria Cocos Extract, Lauryl Alcohol, Magnolia Grandiflora Bark Extract, Saccharide Isomerate, Aloe Barbadensis Leaf Juice, Helichrysum Italicum Extract, Avena Sativa (Oat) Kernel Extract

Section 51945-4 (51945-4)

DIME

ACNE SPOT TREATMENT

SALICYLIC ACID + PROBIOTICS

0.5 FL OZ | 15 ML

Section 55105-1 (55105-1)

Uses: For the treatment of acne

Section 55106-9 (55106-9)

Active Ingredients: Salicylic Acid 2%

Purpose: Acne medication

Section 60561-8 (60561-8)

Questions?

(801) 996-8274

[email protected]


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)