FDA.reportPublic FDA data

Prime

Manufacturer
Sterling Perfumes Industries LLC
Effective date
2020-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:23:49

Label at a glance#

ProductPrime
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing. Other information Store between 15-30 0 C (59-86 0 F). Avoid freezing and excessive heat above 40 0 C (104 0 F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-300C (59-860F).
Avoid freezing and excessive heat above 400C (1040F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Propylene Glycol, Isopropyl Myristate, Benzalkonium Chloride, Fragrance, Tocopheryl Acetate, Aloe barbadensis Leaf Extract.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 50 mL

Label1Label1

Label 100 mL

Label2Label2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77716-016-012025-01-21C16284748780-1d6a99b39-aaa1-a426-e053-dadaa90af4c21a834ccd-4076-42e2-8485-4bf375a6cbfa
77716-016-022025-01-21C16284748780-1d6a99b39-aaa1-a426-e053-dadaa90af4c21a834ccd-4076-42e2-8485-4bf375a6cbfa
77716-016-012022-01-28C16284748780-1d6a99b39-aaa1-a426-e053-dadaa90af4c21a834ccd-4076-42e2-8485-4bf375a6cbfa
77716-016-022022-01-28C16284748780-1d6a99b39-aaa1-a426-e053-dadaa90af4c21a834ccd-4076-42e2-8485-4bf375a6cbfa

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77716-01677716-016-01, 77716-016-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
Isopropyl Myristate0RE8K4LNJSIACT
Benzalkonium ChlorideF5UM2KM3W7IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT

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
2c418a97-4e30-dfc2-e063-6394a90af0841a834ccd-4076-42e2-8485-4bf375a6cbfa2025-01-21WarningsExact identifier
spl set id: 1a834ccd-4076-42e2-8485-4bf375a6cbfa

Reported adverse events (FAERS/openFDA)#

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