72476-004- Careone Amber

72476-004- Careone Amber
SPL v4
SPL
SPL Set ID cb8fdf26-8372-70d8-e053-2995a90a840a
Route
TOPICAL
Published
Effective Date 2021-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (130 mg)
Inactive Ingredients
Coco Monoethanolamide Lauramidopropylamine Oxide Sodium Chloride Sodium Sulfate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Red No. 40 Water Glycerin Cetrimonium Chloride Peg-120 Methyl Glucose Dioleate Fragrance Clean Orc0600327 Citric Acid Monohydrate Edetate Sodium Fd&c Yellow No. 5 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-01
Description

Benzalkonium Chloride (0.13%)

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride (0.13%)

Pdp2

Pdp3

Pdp4

Uses

Helps eliminate bacteria on hands.

Warnings

For external use only

Directions
  • apply onto wet hands (only for 222 ml and 333 ml)
  • Lather and rinse thoroughly.(For all packages)
  • From a pump bottle, apply onto wet hands (only for 1.66 L bottle)
  • Use to refill a pump bottle (only for 1.66 L bottle)
Other Information

Store at Room Temperature

Active Ingredient.

Benzalkonium Chloride (0.13%)

Inactive Ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).

Questions Or Comments?

1-877-846-9949

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

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact Poison Control Center immediately.

Structured Label Content

Pdp2 (PDP2)

Pdp3 (PDP3)

Pdp4 (PDP4)

Uses

Helps eliminate bacteria on hands.

Purpose

Antibacterial

Warnings

For external use only

Directions
  • apply onto wet hands (only for 222 ml and 333 ml)
  • Lather and rinse thoroughly.(For all packages)
  • From a pump bottle, apply onto wet hands (only for 1.66 L bottle)
  • Use to refill a pump bottle (only for 1.66 L bottle)
Other Information

Store at Room Temperature

Active Ingredient.

Benzalkonium Chloride (0.13%)

Inactive Ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).

Questions Or Comments? (Questions or comments?)

1-877-846-9949

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

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

In case of accidental ingestion, get medical help or contact Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:54.992811 · Updated: 2026-03-14T23:04:16.644897