FDA.reportPublic FDA data

Smart Care WATERMELON HAND SANITIZER

Product NDC
70108-109
11-digit product format
701080109
Labeler code
70108
Product ID
70108-109_6af54cc7-5c88-4700-b94f-bf353f486c9b
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Ashtel Studios Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-29
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Smart Care WATERMELON HAND SANITIZER
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
70108-109-01Smart Care WATERMELON HAND SANITIZER30 mL in 1 BOTTLE, SPRAYSPRAY304
70108-109-01Smart Care WATERMELON HAND SANITIZER1 in 1 BOXSPRAY14
70108-109-02Smart Care WATERMELON HAND SANITIZER1 in 1 BOXSPRAY14
70108-109-02Smart Care WATERMELON HAND SANITIZER40 mL in 1 BOTTLE, SPRAYSPRAY404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-109SMART CARE WATERMELON HAND SANITIZER (ETHYL ALCOHOL) SPRAY [ASHTEL STUDIOS INC.]1Current NDC, 4 package rows20250131_dd40b8d2-7b6e-4bfc-8a52-a852c3ffe45b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041849ethanol 70 % Topical SprayPSNdd40b8d2-7b6e-4bfc-8a52-a852c3ffe45b4
1041849ethanol 0.7 ML/ML Topical SpraySCDdd40b8d2-7b6e-4bfc-8a52-a852c3ffe45b4
1041849ethanol 70 % Topical SpraySYdd40b8d2-7b6e-4bfc-8a52-a852c3ffe45b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70108-109-01701080109011 BOTTLE, SPRAY in 1 BOX (70108-109-01) / 30 mL in 1 BOTTLE, SPRAY2025-01-29NoNoHistorical
70108-109-02701080109021 BOTTLE, SPRAY in 1 BOX (70108-109-02) / 40 mL in 1 BOTTLE, SPRAY2025-09-16NoNoHistorical