CREAMOL ANTIBACTERIAL WET WIPES 40 PCS- benzalkonium chloride swab

Creamol Antibacterial Wet Wipes 40 pcs by

Drug Labeling and Warnings

Creamol Antibacterial Wet Wipes 40 pcs by is a Otc medication manufactured, distributed, or labeled by Laber Kimya AR-GE Sanayi Ticaret-Levent KAHRIMAN, Laber Kimya AR-GE Sanayi Ticaret Levent KAHRIMAN. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium chloride (Quaternary ammonium compounds, benzyl (C12-16) alkyldimethyl, chlorides) %0,13 (w/w). Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer Wet Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

· in children less than 2 months of age

· on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

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.

Directions

Wipe hands; discard

Other Information

· Store between 15-30 °C (59-86 °F)

· Avoid freezing and excessive heat above 40 °C (104 °F)

Inactive Ingredients

Aqua, Glycerin, Phenoxyethanol, Polysorbate 20, Sodium PCA, Tetrasodium EDTA, Ethylhexylglycerin, Citric acid

Package Panel- Principal Display Panel

INGREDIENTS AND APPEARANCE

CREAMOL ANTIBACTERIAL WET WIPES 40 PCS 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77892-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77892-022-01	4 g in 1 POUCH; Type 0: Not a Combination Product	11/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/18/2020

Labeler - Laber Kimya AR-GE Sanayi Ticaret-Levent KAHRIMAN (533149962)

Establishment
Name	Address	ID/FEI	Business Operations
Laber Kimya AR-GE Sanayi Ticaret Levent KAHRIMAN		533149962	manufacture(77892-022)