inoderm style antibacterial soap

inoderm style antibacterial soap
SPL v2
SPL
SPL Set ID 2cfb272d-25c2-46a8-a337-f15056fd8837
Route
topical
Published
Effective Date 2023-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chloroxylenol (3 mg)
Inactive Ingredients
water sodium laureth-3 sulfate sodium chloride coco monoisopropanolamide sodium sulfate magnesium nitrate citric acid monohydrate fd&c yellow no. 5 methylchloroisothiazolinone magnesium chloride methylisothiazolinone fd&c red no. 4

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-03-16

Purpose

Antiseptic

Description

Chloroxylenol 0.3% w/w


Medication Information

Warnings

For external use only.

Uses

• For handwashing to help reduce bacteria on the skin. • Recommended for repeated use.

Purpose

Antiseptic

Directions

• Wet hands with water and dispense small amount of product into cupped palm of hand. • Lather vigorously for at least 15 seconds. • Rinse with water and dry thoroughly.

Inactive Ingredients

Water, Sodium Lauryl Ether Sulfate, Sodium Chloride, Cocamide MIPA, Sodium Sulfate, Fragrance, Magnesium Nitrate, Citric Acid, FD&C Yellow # 5, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red # 4

Description

Chloroxylenol 0.3% w/w

Drug Facts

Active Ingredient

Chloroxylenol 0.3% w/w

Package Labeling:

When Using This Product

keep away from eyes. In case of eye contact, flush eyes with water.

Stop Use and Ask A Doctor If

irritation or redness develop 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

Warnings

For external use only.

Uses

• For handwashing to help reduce bacteria on the skin. • Recommended for repeated use.

Purpose

Antiseptic

Directions

• Wet hands with water and dispense small amount of product into cupped palm of hand. • Lather vigorously for at least 15 seconds. • Rinse with water and dry thoroughly.

Inactive Ingredients (Inactive ingredients)

Water, Sodium Lauryl Ether Sulfate, Sodium Chloride, Cocamide MIPA, Sodium Sulfate, Fragrance, Magnesium Nitrate, Citric Acid, FD&C Yellow # 5, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, FD&C Red # 4

Drug Facts

Active Ingredient (Active ingredient)

Chloroxylenol 0.3% w/w

Package Labeling:

When Using This Product (When using this product)

keep away from eyes. In case of eye contact, flush eyes with water.

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

irritation or redness develop 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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