Circle B Manufacturing Foaming Alcohol Free Hand Sanitizer

Circle B Manufacturing Foaming Alcohol Free Hand Sanitizer
SPL v1
SPL
SPL Set ID ba47353a-5c17-07f2-e053-2995a90aa24f
Route
TOPICAL
Published
Effective Date 2021-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 mg)
Inactive Ingredients
Water Lauramine Oxide Undeceth-7 Edetate Disodium Anhydrous Dmdm Hydantoin Citric Acid Monohydrate Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-19

Description

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.1%

Uses

- For hand sanitizing to decrease the bacteria on skin.

- Recommended for repeated use

Warnings

For external use only

Directions

- Pump a small amount of foam into palm of hand

- Rub thoroughly over all surfaces of both hands

- Rub hands together to produce a thick lather

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1%

Package Labeling:

Inactive Ingredients:

Water, Lauramine Oxide, Undeceth-7, Disodium EDTA, DMDM Hydantoin, Fragrance, Citric Acid, FD&C Red #33, FD&C Blue #1.

Package Labeling:3790ml

When Using This Product

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use and Ask A Doctor

if irritation or redness develops, or if condition persists 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 sanitizing to decrease the bacteria on skin.

- Recommended for repeated use

Purpose

Antimicrobial

Warnings

For external use only

Directions (DIRECTIONS)

- Pump a small amount of foam into palm of hand

- Rub thoroughly over all surfaces of both hands

- Rub hands together to produce a thick lather

Drug Facts

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.1%

Package Labeling:

Inactive Ingredients: (Inactive ingredients:)

Water, Lauramine Oxide, Undeceth-7, Disodium EDTA, DMDM Hydantoin, Fragrance, Citric Acid, FD&C Red #33, FD&C Blue #1.

Package Labeling:3790ml

When Using This Product (When using this product)

avoid contact with eyes. In case of eye contact, flush eyes with water.

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

if irritation or redness develops, or if condition persists 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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