FDA.reportPublic FDA data

Acne Spot Treatment

Manufacturer
Natural Immunogenics | Inspec Solutions
Effective date
2025-08-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:34:51

Label at a glance#

ProductAcne Spot Treatment
Active ingredientSALICYLIC ACID
Label structure7 sections

Indications and uses

 for treatment of acne • Clears acne blemishes and allows skin to heal. Helps prevent new acne blemishes.

Dosage and administration

ATake a quarter sized amount of the product in wet hands and work into a fine lather. Apply to wet face and massage for 60 seconds. Rinse with warm water and pat the skin dry. Use twice daily.

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

 for treatment of acne • Clears acne blemishes and allows
skin to heal. Helps prevent new acne blemishes.

Warnings

WARNINGS SECTION

For external use only.
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.
Stop use and ask a doctor if• skin irritation occurs or gets worse.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 If swallowed, get medical help
or contact Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

ATake a quarter sized amount of the product in wet hands and work into a fine lather. Apply to wet face and massage for 60 seconds. Rinse with warm water and pat the skin dry. Use twice daily.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

 Arginine, Cocos Nucifera
(Coconut) Fruit Extract, Glycerin, Hydrolized Sodium Hyaluronate,
Lactobacillus, Lactobacillus Ferment, Niacinamide, Panthenol,
Propanediol, Sodium Citrate, Silver, Water, Xantham Gum,
Zinc PCA

Other Information

OTHER SAFETY INFORMATION

Store at room temperature, 68˚F - 78˚F (20˚C - 26˚C), and out of direct sunlight

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52166-03152166-031-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLOYL/CAPROYL METHYL GLUCAMIDE0451R360HRIACT
CITRIC ACID2968PHW8QPIACT
COCO-GLUCOSIDEICS790225BIACT
COCOS NUCIFERA (COCONUT) FRUIT JUICEAMN6S4M09GIACT
GLYCERINPDC6A3C0OXIACT
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER8FP93ED6H2IACT
HYDROLYZED JOJOBA ESTERSUDR641JW8WIACT
LACTOBACILLUS5307V7XW8IIACT
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APIACT
LAUROYL/MYRISTOYL METHYL GLUCAMIDESC667B999PIACT
PROPANEDIOL5965N8W85TIACT
SALIX ALBA BARK205MXS71H7IACT
SILVER3M4G523W1GIACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
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
43e14fac-bbec-ea9d-e063-6394a90a21834b0a562a-9dcd-4489-88ed-46e54dbc1cd72025-11-18WarningsExact identifier
spl set id: 4b0a562a-9dcd-4489-88ed-46e54dbc1cd7

Reported adverse events (FAERS/openFDA)#

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