Acne Spot Treatment — v3

Acne Spot Treatment

10 Views

Version

v3

Effective date

October 1, 2025

Original packager

Yes

Sections captured

10

Identifiers

Document ID
401d4be1-4d7e-f466-e063-6294a90ad526
Set ID
f7fd3f24-7c27-b45b-e053-6394a90a50ae
Application numbers
M006
Product NDCs
82870-006
Package NDCs
82870-006-01
Original packager NDCs

Names & Manufacturers

Brand names
Acne Spot Treatment
Generic names
SALICYLIC ACID
Manufacturer names
Dime Beauty Co, LLC
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
SALICYLIC ACID
Routes
TOPICAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
317152
UNII
O414PZ4LPZ
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredients: Salicylic Acid 2% Purpose: Acne medication
Dosage And Administration (1)

Sequence 1

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
Inactive Ingredient (1)

Sequence 1

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
Indications And Usage (1)

Sequence 1

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.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help ro contact a Poison Control Center right away.
Other Safety Information (1)

Sequence 1

Questions? (801) 996-8274 hello@dimebeautyco.com
Package Label Principal Display Panel (1)

Sequence 1

DIME ACNE SPOT TREATMENT SALICYLIC ACID + PROBIOTICS 0.5 FL OZ | 15 ML Acne Spot Bottle Acne Spot carton
Purpose (1)

Sequence 1

Uses: For the treatment of acne
Spl Product Data Elements (1)

Sequence 1

Acne Spot Treatment Salicylic Acid 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 SALICYLIC ACID SALICYLIC ACID DICAPRYLYL ETHER WATER OAT ALOE VERA LEAF SACCHARIDE ISOMERATE 1,2-HEXANEDIOL SOYBEAN OIL LAMINARIA DIGITATA LAURYL ALCOHOL OCTYLDODECANOL GLYCERIN TETRASODIUM GLUTAMATE DIACETATE
Warnings (1)

Sequence 1

Warning: For external use only

OpenFDA raw payload

{'application_number': ['M006'],
 'brand_name': ['Acne Spot Treatment'],
 'generic_name': ['SALICYLIC ACID'],
 'is_original_packager': [True],
 'manufacturer_name': ['Dime Beauty Co, LLC'],
 'package_ndc': ['82870-006-01'],
 'product_ndc': ['82870-006'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['317152'],
 'spl_id': ['401d4be1-4d7e-f466-e063-6294a90ad526'],
 'spl_set_id': ['f7fd3f24-7c27-b45b-e053-6394a90a50ae'],
 'substance_name': ['SALICYLIC ACID'],
 'unii': ['O414PZ4LPZ']}