drug facts

drug facts
SPL v1
SPL
SPL Set ID 08a0d54b-267d-4d2a-8189-bb4fe9d261a1
Route
topical
Published
Effective Date 2011-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.1 mL)
Inactive Ingredients
water aloe vera leaf green tea leaf dmdm hydantoin sodium hydroxide octinoxate avobenzone octisalate polyoxyl 40 hydrogenated castor oil fd&c blue no. 1 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2011-10-06
Purpose

ANTISEPTIC

Description

BENZALKONIUM CHLORIDE 0.1%

Medication Information

Warnings

FOR EXTERNAL USE ONLY.

Uses

TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEAT USE.

Purpose

ANTISEPTIC

Directions
  • PUMP DESIRED AMOUNT ONTO HANDS AND RUB UNTIL YOUR SKIN IS DRY.
  • CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Inactive Ingredients

WATER, ALOE BARBADENSIS LEAF JUICE, CAMELLIA SINENSIS LEAF EXTRACT, FRAGRANCE, DMDM HYDANTOIN, SODIUM HYDROXIDE, ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, PPG-26-BUTETH-26, PEG-40 HYDROGENATED CASTOR OIL, BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

Description

BENZALKONIUM CHLORIDE 0.1%

Section 51945-4

Active Ingredient
BENZALKONIUM CHLORIDE 0.1%

When Using This Product

AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE WITH WATER. AVOID CONTACT WITH BROKEN SKIN.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask Doctor If

IRRITATION OR RASH DEVELOPS AND LASTS.

Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEAT USE.

Purpose (PURPOSE)

ANTISEPTIC

Directions (DIRECTIONS)
  • PUMP DESIRED AMOUNT ONTO HANDS AND RUB UNTIL YOUR SKIN IS DRY.
  • CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, ALOE BARBADENSIS LEAF JUICE, CAMELLIA SINENSIS LEAF EXTRACT, FRAGRANCE, DMDM HYDANTOIN, SODIUM HYDROXIDE, ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, PPG-26-BUTETH-26, PEG-40 HYDROGENATED CASTOR OIL, BLUE 1 (CI 42090), YELLOW 5 (CI 19140).

Section 51945-4 (51945-4)

Active Ingredient (ACTIVE INGREDIENT)
BENZALKONIUM CHLORIDE 0.1%

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES.  IF CONTACT OCCURS, RINSE WITH WATER. AVOID CONTACT WITH BROKEN SKIN.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask Doctor If (STOP USING THIS PRODUCT AND ASK DOCTOR IF)

IRRITATION OR RASH DEVELOPS AND LASTS.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:21.029263 · Updated: 2026-03-14T22:52:53.430326