SPL v3
SPL
SPL Set ID a65a6434-eaa2-0f7d-e053-2a95a90acd0f
Route
TOPICAL
Published
Effective Date 2020-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Water Cetylpyridinium Chloride Citric Acid Monohydrate Hydroxyacetophenone Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-24

Description

Benzalkonium chloride 0.1%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride 0.1%

Warning

Flammable. Keep away from heat or flame.

Use only as intended and according to the directions of use.

Directions

1. Open the cover, Pick as much as you needs, Wipe your body gently.

2. Put sticker after using. There is risk of drying.

3. Use it as soon as possible after opening.

Supervise children under 6 years of age when using this product to avoid swallowing.

Package Label

Other Information

1. Store in cool and shady place, between 15-30C (59-86F)

2. May discolor certain fabrics or surfaces.

Active Ingredients

Benzalkonium chloride 0.1%

Inactive Ingredient

Purified water, Glycerin, Hydroxyacetophenone, Cetylpyridinium chloride, Citric acid

Avoid Contact With Eyes.

In case of contact, rinse eyes thoroughly with water.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Hand Sanitizer to Hlep Reduce Bacteria

Hypoallergenic.

No harmful chemicals/

Refreshness from no stickness, residue after using.

Keep your hands clean when it's hard to wash your hands.

Do Not Dispose Used Tissue in the Flushing Toilet.

Do not put used tissue into pack again.

There is the risk of degeneration.

Stop Use and Ask A Docotr If Signs Symptoms As Follows:

(1) signs of irritation and/or rash appears

(2) signs of abnormality as above after exposed to sunlight.


Structured Label Content

Purpose

Antiseptic

Warning

Flammable. Keep away from heat or flame.

Use only as intended and according to the directions of use.

Directions

1. Open the cover, Pick as much as you needs, Wipe your body gently.

2. Put sticker after using. There is risk of drying.

3. Use it as soon as possible after opening.

Supervise children under 6 years of age when using this product to avoid swallowing.

Package Label

Other Information (Other information)

1. Store in cool and shady place, between 15-30C (59-86F)

2. May discolor certain fabrics or surfaces.

Active Ingredients (Active ingredients)

Benzalkonium chloride 0.1%

Inactive Ingredient (Inactive ingredient)

Purified water, Glycerin, Hydroxyacetophenone, Cetylpyridinium chloride, Citric acid

Avoid Contact With Eyes. (Avoid contact with eyes.)

In case of contact, rinse eyes thoroughly with water.

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

If swallowed, get medical help or contact a Poison Control Center right away.

Hand Sanitizer to Hlep Reduce Bacteria (Hand Sanitizer to hlep reduce bacteria)

Hypoallergenic.

No harmful chemicals/

Refreshness from no stickness, residue after using.

Keep your hands clean when it's hard to wash your hands.

Do Not Dispose Used Tissue in the Flushing Toilet. (Do not dispose used tissue in the flushing toilet.)

Do not put used tissue into pack again.

There is the risk of degeneration.

Stop Use and Ask A Docotr If Signs Symptoms As Follows: (Stop use and ask a docotr if signs symptoms as follows:)

(1) signs of irritation and/or rash appears

(2) signs of abnormality as above after exposed to sunlight.


Advanced Ingredient Data


Raw Label Data

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