Ndc- 71141-022-02.

Ndc- 71141-022-02.
SPL v4
SPL
SPL Set ID ca58d78e-a85a-da96-e053-2995a90a60a9
Route
TOPICAL
Published
Effective Date 2021-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (130 mg)
Inactive Ingredients
Fd&c Green No. 3 Mordant Yellow 10 Sodium Citrate Cocamidopropyl Betaine Polysorbate 20 Glycerin Decyl Glucoside Aloe Vera Leaf Camellia Sinensis Flower Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Xanthan Gum Methylchloroisothiazolinone Water Methylisothiazolinone Fragrance Clean Orc0600327 Citric Acid Monohydrate Edetate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-04

Description

Benzalkonium Chloride (0.13%)

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride (0.13%)

Uses
  • For hand washing to decrease bacteria on the skin
Warnings

For external use only

Directions
  • Apply onto dry hands
  • Lather and rinse thoroughly with water.
Other Information

Store at room temperature

Active Ingredient.

Benzalkonium Chloride (0.13%)

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquatermium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Green 3 (Cl 42053), Yellow 10 (Cl 47005)

Principal Display Panel

When Using This Product

Avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop Use and Ask A Doctor

If irritation or redness develops and lasts for more than 72 hours

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • For hand washing to decrease bacteria on the skin
Purpose

Antibacterial

Warnings

For external use only

Directions
  • Apply onto dry hands
  • Lather and rinse thoroughly with water.
Other Information

Store at room temperature

Active Ingredient.

Benzalkonium Chloride (0.13%)

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquatermium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Green 3 (Cl 42053), Yellow 10 (Cl 47005)

Principal Display Panel

When Using This Product (When using this product)

Avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

If irritation or redness develops and lasts for more than 72 hours

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.


Advanced Ingredient Data


Raw Label Data

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