78028-004 Anti-bacterial Wet Wipes 0.13% Benzalkonium Chloride

78028-004 Anti-bacterial Wet Wipes 0.13% Benzalkonium Chloride
SPL v3
SPL
SPL Set ID ab2def5c-5033-902a-e053-2a95a90af986
Route
TOPICAL
Published
Effective Date 2020-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Sodium Citrate .alpha.-tocopherol Glycerin Aloe Vera Leaf Poly(laurylglucoside)-7 Propanediol Betaine Cetylpyridinium Chloride Anhydrous Chlorphenesin Water Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-20

Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic/Hand & Skin Sanitizer


Medication Information

Warnings and Precautions

Do not freeze. For external use only, Store at room temperature.

Do not use in ears, eyes or mouth.

Avoid contact with the eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor if redness or irritation develop and persist

for more than 72 hours,

Purpose

Antiseptic/Hand & Skin Sanitizer

Description

Benzalkonium Chloride 0.13%

Use

Sanitizing Hand Wipes to help decrease bacteria on the skin.

Recommended for single use.

Section 50565-1

●Keep out of reach of children.

●Children should be supervised when using this product.

If swallowed, get medical help or contact Poison Control Centre

immediately.

Section 51945-4

Directions

Wipe liberally over the hands & body, rub into skin until dry,

Recommended for single use.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water (Aqua), Glycerol, Propanediol,

Aloe Vera Extract, Amino acid moisturizer,

Hexadecylpyridinium Chloride,Chlorphenesin,

Vitamin E, Dodecyl polyglucoside, Citric acid,

Sodium citrate.


Structured Label Content

Use (USE)

Sanitizing Hand Wipes to help decrease bacteria on the skin.

Recommended for single use.

Warnings and Precautions (34071-1)

Do not freeze. For external use only, Store at room temperature.

Do not use in ears, eyes or mouth.

Avoid contact with the eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor if redness or irritation develop and persist

for more than 72 hours,

Section 50565-1 (50565-1)

●Keep out of reach of children.

●Children should be supervised when using this product.

If swallowed, get medical help or contact Poison Control Centre

immediately.

Section 51945-4 (51945-4)

Purpose

Antiseptic/Hand & Skin Sanitizer

Directions

Wipe liberally over the hands & body, rub into skin until dry,

Recommended for single use.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerol, Propanediol,

Aloe Vera Extract, Amino acid moisturizer,

Hexadecylpyridinium Chloride,Chlorphenesin,

Vitamin E, Dodecyl polyglucoside, Citric acid,

Sodium citrate.


Advanced Ingredient Data


Raw Label Data

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