san

san
SPL v3
SPL
SPL Set ID c058d278-3d6d-7e3c-e053-2995a90a6c2f
Route
topical
Published
Effective Date 2021-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 mg)
Inactive Ingredients
alcohol citric acid monohydrate 1,2-hexanediol aloe vera leaf glycerin butylene glycol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-04-12

Purpose

Antiseptic,

Description

Benzalkonium Chloride 0.13%. Purpose: Antiseptic


Medication Information

Warnings

For external use only.

Purpose

Antiseptic,

Directions

Wet hands thoroughly with product and allow to dry without wiping

Not recommended for infants

Other Information
  • Do not Store above 105F/40 Degree .Do not Freeze
  • Dispose of used wipe in trash, do not flush into toilet
Inactive Ingredients

Water ( Aqua) , Alcohol ( Ethanol). Glycerin,Butylene Glycol, Aloe Vera, Citric Acid, 1,2 hexanediol

Description

Benzalkonium Chloride 0.13%. Purpose: Antiseptic

Use

to decrease bacteria on the skin that could cause disease

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation or redness developes condition persist for more than 72 hours.

Section 50567-7

Keep out of eyes, in case of contact with eyes, flush thoroughly with water, Avoid contact with broken skin, Do Not inhale or ingest

Active Ingredient(s)

Benzalkonium Chloride 0.13%. Purpose: Antiseptic

Package Label Principal Display Panel

120 Wet wipes NDC 75214-120-01


Structured Label Content

Warnings

For external use only.

Purpose

Antiseptic,

Directions

Wet hands thoroughly with product and allow to dry without wiping

Not recommended for infants

Other Information (Other information)
  • Do not Store above 105F/40 Degree .Do not Freeze
  • Dispose of used wipe in trash, do not flush into toilet
Inactive Ingredients (Inactive ingredients)

Water ( Aqua) , Alcohol ( Ethanol). Glycerin,Butylene Glycol, Aloe Vera, Citric Acid, 1,2 hexanediol

Use

to decrease bacteria on the skin that could cause disease

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness developes condition persist for more than 72 hours.

Section 50567-7 (50567-7)

Keep out of eyes, in case of contact with eyes, flush thoroughly with water, Avoid contact with broken skin, Do Not inhale or ingest

Active Ingredient(s)

Benzalkonium Chloride 0.13%. Purpose: Antiseptic

Package Label Principal Display Panel (Package Label - Principal Display Panel)

120 Wet wipes NDC 75214-120-01


Advanced Ingredient Data


Raw Label Data

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