Wet Wipes: Package Insert and Label Information

WET WIPES- benzalkonium chloride swab
GULSAH URETIM PAZARLAMA — HUSEY IN KAYA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antiseptic

Uses

•decreases bacteria on the skin

Warnings

•For external use only

Do not use

•Over large areas of the body if you are allergic to any of the ingredients

When using this product

•do not get into eyes. •If contact occurs, rinse thoroughly with water.

Stop use

Stop use and ask a doctor if irritation or rash develops and continues 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.

Directions

• for adults and children 2 years and over use on hands and face to clean and refresh, allow skin to air dry. For children under 2 years of age ask a doctor before use.

Inactive Ingredients

water, propylene glycol, cocamidopropyl betaine, peg-7 glyceryl cocoate, fragrance, benzyl alcohol, methylchloroisothiazolinine, methylisothiazolinone, tetrasodium EDTA, peg-40 hydrogenated castor oil, cetrimonium chloride, citric acid, aloe vera extract, alphatocopherol acetate

Package Label

WET WIPES benzalkonium chloride swab

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70140-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.1 g

Inactive Ingredients Ingredient Name Strength WATER PROPYLENE GLYCOL COCAMIDOPROPYL BETAINE BENZYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE EDETATE SODIUM CETRIMONIUM CHLORIDE CITRIC ACID MONOHYDRATE ALOE VERA LEAF ALPHA-TOCOPHEROL ACETATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70140-001-30 30 SWAB in 1 PACKAGE None 2 NDC:70140-001-36 36 SWAB in 1 PACKAGE None 3 NDC:70140-001-40 40 SWAB in 1 PACKAGE None 4 NDC:70140-001-16 16 SWAB in 1 PACKAGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/06/2016

Labeler — GULSAH URETIM PAZARLAMA — HUSEY IN KAYA (356137617)

Revised: 10/2017 GULSAH URETIM PAZARLAMA — HUSEY IN KAYA