FDA.reportPublic FDA data

Alcohol Gel 70%

Manufacturer
Plus Cosmetica S.A. | YOBEL SUPPLY CHAIN MANAGEMENT S.A. | Plus Cosmetica S A
Effective date
2020-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:39

Label at a glance#

ProductPlus Cosmetica S A
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Uses * Sanitizer antibacterial helps eliminate bacteria on hands and arms. This product is not a substitute of hands and soap hand washing. Avoid contact with broken or damaged skin

Dosage and administration

Directions: Place enough product in your palm to thoroughly cover your hands and arms. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Ethyl Alcohol 70%............ Antibacterial

Uses

INDICATIONS & USAGE SECTION

Uses

* Sanitizer antibacterial helps eliminate bacteria on hands and arms. This product is not a substitute of hands and soap hand washing. Avoid contact with broken or damaged skin

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable: Keep away from heat and flame. Highly flammable liquid and vapor.
  • When using this products avoid contact with eyes. In case of contact flush with water for several minutes.
  • Keep out of reach of children except under adult supervision. If swallowed, get medical help, or contact a Poison Control

Center right away.

  • Stop use and ask Doctor: if skin irritation develops when using this product.
  • Do not use: do not swallow

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

* Irritation develops while using this product

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children except under adult supervision. If swallow, get medical help or contact a Poison Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Directions: Place enough product in your palm to thoroughly cover your hands and arms. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, acrylates/C10-30 Alkyl Acrylate Crosspolymer, triethanolamine

Questions?

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS: (305) 670 0979. Monday to Friday/ Address: 8950 SW 74 Court. Suite 1406. Miami, Florida 33156

Uses

OTC - PURPOSE SECTION

Uses

* Sanitizer antibacterial helps eliminate bacteria on hands and arms. This product is not a substitute of hands and soap hand washing. Avoid contact with broken or damaged skin

Hand Sanitizer Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78343-002-012021-07-23C16284748780-1c7ccaba7-177f-fd44-e053-dadaa90aa01bAlcohol Gel 70%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78343-002-01Plus Cosmetica S A380 mL in 1 BOTTLE, PLASTICGEL3801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78343-002PLUS COSMETICA S A (ALCOHOL) GEL [PLUS COSMETICA S.A.]1Legacy NDC, 1 package rows20200602_a709d5c4-676c-c498-e053-2995a90a4e04.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78343-00278343-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALCOHOL3K9958V90MACTIB

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
a709d7be-1d17-c78f-e053-2995a90aa34ea709d5c4-676c-c498-e053-2995a90a4e042020-06-01WarningsExact identifier
spl id: a709d7be-1d17-c78f-e053-2995a90aa34e
spl set id: a709d5c4-676c-c498-e053-2995a90a4e04

Reported adverse events (FAERS/openFDA)#

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