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Alcare Extra Hand Sanitizer

Alcohol · Solution

Over-the-counter M Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Alcare Extra Hand Sanitizer
Generic name
Alcohol
Dosage form
Solution
Route
Topical
Marketing category
OTC MONOGRAPH DRUG · OTC MONO
Labeler
SC Johnson Professional USA Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
12
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Alcohol 80 mL/100mL 581662 View
Alcohol 85.6 mL/100mL 581662 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Topical
Presentations
14

Regulatory status

Source: Drugs@FDANDC Directory
Application number
000004
Application type
M
Approval date
July 16, 1969
Sponsor
PHARMICS
Products on application
1
Submissions recorded
3
Products approved under application 000004.
Product Trade name Form Strength Ingredient Status TE Flags
000004-004 PAREDRINE SOLUTION/DROPS HYDROXYAMPHETAMINE HYDROBROMIDE Discontinued —

Approval history

Source: Drugs@FDA
Most recent submissions on application 000004.
Type No. Action Status Date Review
Supplement 11 Labeling Approved May 26, 1987 —
Supplement 10 Labeling Approved May 8, 1980 —
Original application 1 Approved July 16, 1969 Unknown

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260827). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260827 HUMAN OTC DRUG · 20251006

Indications and Usage

openFDA Drug Labeling

Uses for hand sanitizing to reduce bacteria on the skin

Purpose Antibacterial

Dosage and Administration

openFDA Drug Labeling

Directions apply foaming sanitizer to cover hands rub into skin no rinsing required

Warnings For external use only Flammable: Keep away from fire or flame. When using this product avoid contact with eyes. In case of eye contact, flush with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

openFDA Drug Labeling

Active ingredient Ethyl alcohol, 85.6% v/v

Adverse event reports

Source: openFDA FAERS
46,738
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ALCOHOL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
11084-009-01 11084-009 SC Johnson Professional USA Inc. 47 mL in 1 BOTTLE, PLASTIC (11084-009-01) August 24, 2026
11084-009-12 11084-009 SC Johnson Professional USA Inc. 1000 mL in 1 BOTTLE, PLASTIC (11084-009-12) August 24, 2026
11084-009-13 11084-009 SC Johnson Professional USA Inc. 1 BOTTLE, PLASTIC in 1 KIT (11084-009-13) / 1000 mL in 1 BOTTLE, PLASTIC August 24, 2026
11084-009-40 11084-009 SC Johnson Professional USA Inc. 400 mL in 1 BOTTLE, PLASTIC (11084-009-40) August 24, 2026
11084-009-66 11084-009 SC Johnson Professional USA Inc. 1000 mL in 1 BOTTLE (11084-009-66) August 24, 2026
11084-006-01 11084-006 SC Johnson Professional USA, Inc. 47 mL in 1 BOTTLE, PLASTIC (11084-006-01) March 1, 2017
11084-006-12 11084-006 SC Johnson Professional USA, Inc. 1000 mL in 1 BOTTLE, PLASTIC (11084-006-12) March 1, 2017
11084-006-13 11084-006 SC Johnson Professional USA, Inc. 1 BOTTLE, PLASTIC in 1 KIT (11084-006-13) / 1000 mL in 1 BOTTLE, PLASTIC November 1, 2025
11084-006-14 11084-006 SC Johnson Professional USA, Inc. 2 BOTTLE, PLASTIC in 1 BOX (11084-006-14) / 1000 mL in 1 BOTTLE, PLASTIC November 1, 2025
11084-006-27 11084-006 SC Johnson Professional USA, Inc. 1000 mL in 1 BOTTLE, PLASTIC (11084-006-27) March 1, 2017
11084-006-40 11084-006 SC Johnson Professional USA, Inc. 400 mL in 1 BOTTLE, PLASTIC (11084-006-40) March 1, 2017
11084-006-66 11084-006 SC Johnson Professional USA, Inc. 1000 mL in 1 BOTTLE (11084-006-66) February 17, 2023
11084-009 11084-009 SC Johnson Professional USA Inc. — August 24, 2026
11084-006 11084-006 SC Johnson Professional USA, Inc. — March 1, 2017

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 9 sections on this page.