SPL v4
SPL
SPL Set ID d5a5e699-96fb-4b1f-84aa-c38bf4e1fa73
Route
TOPICAL
Published
Effective Date 2021-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (130 mg)
Inactive Ingredients
Water Methylchloroisothiazolinone Glycerin Methylisothiazolinone Cetrimonium Chloride Propylene Glycol Caprylyl Glycol Phenoxyethanol Decyl Glucoside Coco Glucoside Glyceryl Oleate Behentrimonium Chloride Peg-7 Glyceryl Cocoate Polysorbate 20 Aloe Vera Leaf Betaine Fragrance Lemon Orc2001060

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-03-05 Until 2021-04-24

Description

Benzalkonium chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%

Uses

Hand Sanitizer to help reduce bacteria on skin.

Directions

• Pull out one sheet from the pack. Clean hands or affected area.

• Discard wipes in trash receptacle after use.

• Do not flush.

• Close lid after each used to keep wipes fresh.

Drug Facts

Warnings 

For external use only.

When using this productdo not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor ifirritation or rash appears and lasts.

Product Label

Active Ingredient

Benzalkonium chloride 0.13%

Other Information

Store below 104°F (40°C).

Inactive Ingredients

Aqua, Coco Glucoside, Caprylyl Glycol, Cetrimonium Chloride, Behetrimonium Chloride, Decyl Glucoside, PEG-7 Glyceril Cocoate, Glyceril Oleate, Glycerin,Phenoxyethanol, Methylisothiozolinone, Methylchloro Isothiozolinone, Betain, Aloevera Leaf, Polysorbate 20 , Propylene glycol, Fragrance Lemon ORC2001060.

Keep Out of Reach of Children 

except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Hand Sanitizer to help reduce bacteria on skin.

Purpose

Antibacterial

Directions

• Pull out one sheet from the pack. Clean hands or affected area.

• Discard wipes in trash receptacle after use.

• Do not flush.

• Close lid after each used to keep wipes fresh.

Drug Facts

Warnings 

For external use only.

When using this productdo not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor ifirritation or rash appears and lasts.

Product Label (Product label)

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Other Information (Other information)

Store below 104°F (40°C).

Inactive Ingredients (Inactive ingredients)

Aqua, Coco Glucoside, Caprylyl Glycol, Cetrimonium Chloride, Behetrimonium Chloride, Decyl Glucoside, PEG-7 Glyceril Cocoate, Glyceril Oleate, Glycerin,Phenoxyethanol, Methylisothiozolinone, Methylchloro Isothiozolinone, Betain, Aloevera Leaf, Polysorbate 20 , Propylene glycol, Fragrance Lemon ORC2001060.

Keep Out of Reach of Children  (Keep out of reach of children )

except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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