FDA.reportPublic FDA data

VANIBISS BUTT and THIGHS Acne Treatment Cream

Manufacturer
Vanibiss Inc
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:12

Label at a glance#

ProductVANIBISS BUTT and THIGHS Acne Treatment Cream
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

For the treatment of acne.

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.

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

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.

Other information:

SPL UNCLASSIFIED SECTION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbic Acid (Vitamin C), Beeswax, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oil, Centella Asiatica (Gotu Kola) Extarct, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cyclopentasiloxane, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel) Distillate, Hydroxyethyl Acrylate/Sodium (Flax) Seed Oil, Mentha Piperita (Peppermint) Oil, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Rosmarinus Officinalis (Rosemary) Extarct, Salix Alba (Willow) Bark Extarct, Sodium Hydroxide, Sorbitan Olivate, Tetrasodium EDTA, Thymus Vulgaris (Thyme) Extarct, Zemea (Corn) propanediol, Zinc Oxide.

Questions?

OTC - QUESTIONS SECTION

1-800-410-8461

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317152salicylic acid 2 % Topical CreamPSN2
317152salicylic acid 20 MG/ML Topical CreamSCD2
317152salicylic acid 2 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81890-192-00VANIBISS BUTT and THIGHS Acne Treatment Cream1 in 1 BOXCREAM12
81890-192-00VANIBISS BUTT and THIGHS Acne Treatment Cream118.3 mL in 1 JARCREAM118.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81890-192VANIBISS BUTT AND THIGHS ACNE TREATMENT CREAM (SALICYLIC ACID) CREAM [VANIBISS INC]2Current NDC, Legacy NDC, 2 package rows20231112_a0a75b54-e484-4e89-bdf2-e2c864cd2734.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81890-19281890-192-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SAFFLOWER4VBL71TY4YIACT
CENTELLA ASIATICA LEAF6810070TYDIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETEARYL OLIVATE58B69Q84JOIACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSIACT
LINSEED OIL84XB4DV00WIACT
PEPPERMINT OILAV092KU4JHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
ROSEMARYIJ67X351P9IACT
SALIX ALBA BARK205MXS71H7IACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITAN OLIVATEMDL271E3GRIACT
EDETATE SODIUMMP1J8420LUIACT
THYMECW657OBU4NIACT
CORN0N8672707OIACT
ZINC OXIDESOI2LOH54ZIACT
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
VANIBISS BUTT and THIGHS Acne Treatment CreamSALICYLIC ACIDVanibiss Inca0a75b54-e484-4e89-bdf2-e2c864cd27342023-11-11WarningsExact identifier
ndc (package): 81890-192-00
ndc (product): 81890-192
ndc11 (package): 81890019200
spl id: 09e2e5e3-aaf0-d4b0-e063-6294a90a1f57
spl set id: a0a75b54-e484-4e89-bdf2-e2c864cd2734

Reported adverse events (FAERS/openFDA)#

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