1302 Cleansing Towelettes Ndc 67777-244-01

1302 Cleansing Towelettes Ndc 67777-244-01
SPL v24
SPL
SPL Set ID 10454042-ff2e-44ce-b2e2-436cc004897f
Route
TOPICAL
Published
Effective Date 2022-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Chlorothymol Isopropyl Alcohol Water Methylchloroisothiazolinone/methylisothiazolinone Mixture

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-04-05

Description

Benzalkonium Chloride 0.13% v/v

Purpose

First Aid Antiseptic


Medication Information

Purpose

First Aid Antiseptic

Description

Benzalkonium Chloride 0.13% v/v

Uses

• For perineal and maternity care throughout postpartum and whenever refreshing is needed.

Label

1302 Label

Warnings

For external use only

Directions

• Unfold towel

• Cleanse the desired area

• Dispose of towlette after single use.

Do Not Use

• In the eye

Active Ingredient

Benzalkonium Chloride 0.13% v/v

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat.

• Tamper evident. Do not use if packet is torn or cut.

Inactive Ingredients

Chlorothymol, Isopropyl Acohol, Water, may contain Methylchloroisothiazolinone/Methylisothiazolinone

Stop Use and Ask A Doctor If

• Irritation and redness develop

• If condition persists for gets worse

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Uses

• For perineal and maternity care throughout postpartum and whenever refreshing is needed.

Label

1302 Label

Purpose

First Aid Antiseptic

Warnings

For external use only

Directions

• Unfold towel

• Cleanse the desired area

• Dispose of towlette after single use.

Do Not Use (Do not use)

• In the eye

Active Ingredient

Benzalkonium Chloride 0.13% v/v

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat.

• Tamper evident. Do not use if packet is torn or cut.

Inactive Ingredients (Inactive ingredients)

Chlorothymol, Isopropyl Acohol, Water, may contain Methylchloroisothiazolinone/Methylisothiazolinone

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

• Irritation and redness develop

• If condition persists for gets worse

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)