FDA.reportPublic FDA data

B-Pure Moisturizing Hand Sanitizer Coconut Praline Scented Limited Edition

Product NDC
80684-190
11-digit product format
806840190
Labeler code
80684
Product ID
80684-190_459aa6b9-008c-15db-e063-6294a90afc8a
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Fourstar Group USA, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-20
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Moisturizing Hand Sanitizer Coconut Praline Scented Limited EditionALCOHOLFourstar Group USA, Inc.64ea1fcf-026b-4179-8a9d-219818e00e4a2025-12-10WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. Flammable, keep away from fire or flame. Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation, excessive redness or rash develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
B-Pure Moisturizing Hand Sanitizer Coconut Praline Scented Limited Edition
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui1041849

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-190-01B-Pure Moisturizing Hand Sanitizer Coconut Praline Scented Limited Edition34 mL in 1 BOTTLELIQUID341

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041849ethanol 70 % Topical SprayPSN64ea1fcf-026b-4179-8a9d-219818e00e4a1
1041849ethanol 0.7 ML/ML Topical SpraySCD64ea1fcf-026b-4179-8a9d-219818e00e4a1
1041849ethanol 70 % Topical SpraySY64ea1fcf-026b-4179-8a9d-219818e00e4a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80684-190-018068401900134 mL in 1 BOTTLE (80684-190-01) 34 ml2025-11-20NoNoCurrent