above hand sani antiseptic

above hand sani antiseptic
SPL v1
SPL
SPL Set ID ad4035c0-6792-7082-e053-2995a90a7d94
Route
topical
Published
Effective Date 2020-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1 mg)
Inactive Ingredients
water alcohol butane propane glycerin isobutane cocamidopropyl betaine .alpha.-tocopherol acetate peg-12 dimethicone imidurea sodium benzoate propylene glycol sodium chloride tea tree oil sodium citrate benzoic acid citric acid monohydrate benzyl benzoate citral .beta.-citronellol, (r)- geraniol limonene, (+)- .alpha.-hexylcinnamaldehyde linalool, (+/-)-

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-08-14

Purpose

antiseptic

Description

Benzalkonium Chloride (0,10%)


Medication Information

Warnings

FLAMMABLE. DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING. CAN  CAUSE SERIOUS INJURY OR DEATH

  • KEEP AWAY FROM FACE AND MOUTH TO AVOID CONTACT 
Uses

Hand sanitizer to help decrease bacteria on the skin. Recommended for repeated use

Purpose

antiseptic

Directions

Shake well before using. Put a small amount in your palm and rub hands together briskly until dry, always holding the container in an upright position. No rinsing required. No towels needed. 

Inactive Ingredients

AQUA / ALCOHOL / BUTANE / PROPANE / GLYCERIN / ISOBUTANE / COCAMIDOPROPYL BETAINE / TOCOPHERYL ACETATE / PEG-12 DIMETHICONE / IMIDAZOLIDINYL UREA / SODIUM BENZOATE / PROPYLENE GLYCOL / ALOE BARBADENSIS EXTRACT / SODIUM CHLORIDE / MELALEUCA ALTERNIFOLIA LEAF OIL / EUGENIA CARYOPHYLLUS LEAF OIL / SODIUM CITRATE / BENZOIC ACID / CITRIC ACID / PARFUM (BENZYL BENZOATE / CITRAL / CITRONELLOL /GERANIOL / LIMONENE / HEXYL CINNAMAL / LINALOOL).

Description

Benzalkonium Chloride (0,10%)

Questions?

e-mail [email protected] or call: +1 (305) 677-5030

Do Not Use

IN OR NEAR THE EYES. IN CASE OF CONTACT WITH EYES, RINSE THOROUGHLY WITH WATER. CONTENTS UNDER PRESSURE. DO NOT

PUNCTURE OR INCINERATE. DO NOT EXPOSE TO HEAT, SUNLIGHT OR STORE AT TEMPERATURES ABOVE 120°F/50°C OR IN ENCLOSED PLACES THAT COULD OVERHEAT

  • DO NOT USE ON BROKEN SKIN.
Stop Use If

RASH OR IRRITATION OCCURS. GET MEDICAL ATTENTION IMMEDIATELY

Active Ingredient

Benzalkonium Chloride (0,10%)

Package Labeling:

Keep Out of Reach Of children

AND ANIMALS USE ONLY AS DIRECTED. FOR EXTERNAL USE ONLY. IF SWALLOWED, DO NOT INDUCE VOMITING. CONSULT YOUR HEALTHCARE PROVIDER IMMEDIATELY DO NOT LEAVE THE AEROSOL CONTAINER IN A VEHICLE. RISK OF LEAKAGE AND EXPLOSION. CONTAINER MATERIAL: ALUMINUM BATCH AND EXPIRATION ON THE BOTTOM OF THE CONTAINER.


Structured Label Content

Warnings

FLAMMABLE. DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING. CAN  CAUSE SERIOUS INJURY OR DEATH

  • KEEP AWAY FROM FACE AND MOUTH TO AVOID CONTACT 
Uses

Hand sanitizer to help decrease bacteria on the skin. Recommended for repeated use

Purpose

antiseptic

Directions

Shake well before using. Put a small amount in your palm and rub hands together briskly until dry, always holding the container in an upright position. No rinsing required. No towels needed. 

Inactive Ingredients (Inactive ingredients)

AQUA / ALCOHOL / BUTANE / PROPANE / GLYCERIN / ISOBUTANE / COCAMIDOPROPYL BETAINE / TOCOPHERYL ACETATE / PEG-12 DIMETHICONE / IMIDAZOLIDINYL UREA / SODIUM BENZOATE / PROPYLENE GLYCOL / ALOE BARBADENSIS EXTRACT / SODIUM CHLORIDE / MELALEUCA ALTERNIFOLIA LEAF OIL / EUGENIA CARYOPHYLLUS LEAF OIL / SODIUM CITRATE / BENZOIC ACID / CITRIC ACID / PARFUM (BENZYL BENZOATE / CITRAL / CITRONELLOL /GERANIOL / LIMONENE / HEXYL CINNAMAL / LINALOOL).

Questions?

e-mail [email protected] or call: +1 (305) 677-5030

Do Not Use (DO NOT USE)

IN OR NEAR THE EYES. IN CASE OF CONTACT WITH EYES, RINSE THOROUGHLY WITH WATER. CONTENTS UNDER PRESSURE. DO NOT

PUNCTURE OR INCINERATE. DO NOT EXPOSE TO HEAT, SUNLIGHT OR STORE AT TEMPERATURES ABOVE 120°F/50°C OR IN ENCLOSED PLACES THAT COULD OVERHEAT

  • DO NOT USE ON BROKEN SKIN.
Stop Use If (STOP USE IF)

RASH OR IRRITATION OCCURS. GET MEDICAL ATTENTION IMMEDIATELY

Active Ingredient

Benzalkonium Chloride (0,10%)

Package Labeling:

Keep Out of Reach Of children (KEEP OUT OF REACH OF CHILDREN)

AND ANIMALS USE ONLY AS DIRECTED. FOR EXTERNAL USE ONLY. IF SWALLOWED, DO NOT INDUCE VOMITING. CONSULT YOUR HEALTHCARE PROVIDER IMMEDIATELY DO NOT LEAVE THE AEROSOL CONTAINER IN A VEHICLE. RISK OF LEAKAGE AND EXPLOSION. CONTAINER MATERIAL: ALUMINUM BATCH AND EXPIRATION ON THE BOTTOM OF THE CONTAINER.


Advanced Ingredient Data


Raw Label Data

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