FDA.reportPublic FDA data

Annie

Manufacturer
ANNIE INTERNATIONAL, INC
Effective date
2020-05-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:11:28

Label at a glance#

ProductAnnie
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Apply the sanitizer to the palm of one hand and rub all over hands until your hands are dry Children under 6 years of age should be supervised when using

Storage and handling

Store below 110°F (43°C) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame

For external use only.

When using this product

OTC - WHEN USING SECTION

do not use it near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash appears and lasts

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply the sanitizer to the palm of one hand and rub all over hands until your hands are dry
  • Children under 6 years of age should be supervised when using

Other information

STORAGE AND HANDLING SECTION

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Carbomer, Propylene Glycol, Sodium Hydroxide, Parfum (Fragrance), Aloe Barbadensis Leaf Extract

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 75629-075-03

annie®

MOISTURIZING HAND SANITIZER GEL WITH ALOE VERA

Kills 99.9% of Most Germs

3.38 OZ (100mL)

LabelLabel

NDC 75629-075-09

annie®

MOISTURIZING HAND SANITIZER GEL WITH ALOE VERA

Kills 99.9% of Most Germs

9.5 OZ (280mL)

Label 1Label 1

NDC 75629-075-17

annie®

MOISTURIZING HAND SANITIZER GEL WITH ALOE VERA

Kills 99.9% of Most Germs

16.91 OZ (500mL)

Label 2Label 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75629-075-032022-01-28C16284748780-1d6a99b39-8c16-a426-e053-dadaa90af4c29637bf1e-a1ae-48f8-aa7a-8004ca601650
75629-075-092022-01-28C16284748780-1d6a99b39-8c16-a426-e053-dadaa90af4c29637bf1e-a1ae-48f8-aa7a-8004ca601650
75629-075-172022-01-28C16284748780-1d6a99b39-8c16-a426-e053-dadaa90af4c29637bf1e-a1ae-48f8-aa7a-8004ca601650

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75629-075-03Annie100 mL in 1 BOTTLEGEL1004
75629-075-09Annie280 mL in 1 BOTTLEGEL2804
75629-075-17Annie500 mL in 1 BOTTLEGEL5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75629-075ANNIE (ALCOHOL) GEL [ANNIE INTERNATIONAL, INC]4Legacy NDC, 3 package rows20200515_9637bf1e-a1ae-48f8-aa7a-8004ca601650.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75629-07575629-075-03, 75629-075-09, 75629-075-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM HYDROXIDE55X04QC32IIACT
ALOE VERA LEAFZY81Z83H0XIACT

Source Document#

Source XML · Source PDF

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
8dcd5249-aef7-4172-a494-2e6ee52a2bf09637bf1e-a1ae-48f8-aa7a-8004ca6016502020-05-14WarningsExact identifier
spl id: 8dcd5249-aef7-4172-a494-2e6ee52a2bf0
spl set id: 9637bf1e-a1ae-48f8-aa7a-8004ca601650

Reported adverse events (FAERS/openFDA)#

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