FDA.reportPublic FDA data

CANAFARMA Spot On Acne Treatment Cream

Manufacturer
Canafarma Corp.
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:21:05

Label at a glance#

ProductCANAFARMA Spot On Acne Treatment
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

For the treatment of acne.  Penetrates pores to clear most acne blemishes, acne pimples, blackheads, or whiteheads.

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 or 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

PURPOSE

OTC - PURPOSE SECTION

Acne Treatment

USES:

INDICATIONS & USAGE SECTION

  • For the treatment of acne. 
  • Penetrates pores to clear most acne blemishes, acne pimples, blackheads, or whiteheads.

WARNINGS

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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.

If pregnant,

PREGNANCY SECTION

  • ask a health professional before use.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • 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 if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Inactive ingredients: Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Cannabis Sativa (European Hemp) Oil, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, DMAE Bitartrate, Dimethicone, Fucus Vesiculosus (Seaweed) Extract, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Hydrogen Peroxide, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methylisothiazolinone, Polysorbate-20, Retinol (Vitamin A), Salix Alba (Willow) Bark Extract, Sodium Hydroxide, Sodium PCA, Sodium Pyrophosphate, Tocopheryl Acetate (Vitamin E), Xanthan Gum

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun. 

QUESTIONS?

OTC - QUESTIONS SECTION

1-800-871-7143

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80818-24680818-246-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SHEA BUTTERK49155WL9YIACT
CANNABIS SATIVA FLOWERING TOP8X454SZ22DIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETYL ALCOHOL936JST6JCNIACT
CHAMOMILEFGL3685T2XIACT
DEANOL BITARTRATED240J05W14IACT
DIMETHICONE92RU3N3Y1OIACT
FUCUS VESICULOSUS535G2ABX9MIACT
GLYCERINPDC6A3C0OXIACT
LICORICE61ZBX54883IACT
HYDROGEN PEROXIDEBBX060AN9VIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
TEA TREE OILVIF565UC2GIACT
PEPPERMINT OILAV092KU4JHIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
POLYSORBATE 207T1F30V5YHIACT
RETINOLG2SH0XKK91IACT
SALIX ALBA BARK205MXS71H7IACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2aa00163-fe52-0568-e063-6394a90aebdaedee685e-e10d-46e8-bc28-2f8419ce35b42025-01-01WarningsExact identifier
spl set id: edee685e-e10d-46e8-bc28-2f8419ce35b4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.