San

San
SPL v1
SPL
SPL Set ID bfd6a6aa-4250-ed7c-e053-2995a90a71af
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
Citric Acid Monohydrate Alcohol 1,2-hexanediol Aloe Vera Leaf Glycerin Butylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-04-12

Description

Benzalkonium Chloride 0.13%. Purpose: Antiseptic

Purpose

Antiseptic,


Medication Information

Purpose

Antiseptic,

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

Warnings

For external use only.

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
Active Ingredient(s)

Benzalkonium Chloride 0.13%. Purpose: Antiseptic

Inactive Ingredients

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

Package Label Principal Display Panel

120 Wet wipes NDC 81764-120-01


Structured Label Content

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

Purpose

Antiseptic,

Warnings

For external use only.

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
Active Ingredient(s)

Benzalkonium Chloride 0.13%. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

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

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

120 Wet wipes NDC 81764-120-01


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)