Wet Wipes

Wet Wipes
SPL v1
SPL
SPL Set ID a84c95b7-1559-12da-e053-2995a90a3916
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (3 g) Phenoxyethanol (0.3 g)
Inactive Ingredients
Citric Acid Acetate Polysorbate 20 Chamomile Aloe Vera Leaf Alpha-tocopherol Acetate Water Cocamidopropyl Hydroxysultaine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-18

Description

Quaternary ammonium, Phenoxyethanol

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Quaternary ammonium, Phenoxyethanol

Use

Decreases bacteria on skin. Recommended for repeated use

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Warnings

For external use only. Flammable, keep product away from fire or flame.

Do not use over large areas of the body if you are allergic to any of the ingredients when using this product,avoid contact with eyes and face.If contact occurs,flush thoroughly with water.Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Directions

For adults and children of 2 years and over.children under 2 years ask a doctor before use.

Wet hands thoroughly with product and allow to dry without wiping.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Quaternary ammonium, Phenoxyethanol

Inactive Ingredients

Water,Glycerin,Polysorbate 20,Aloe Barbadensis Leaf Extract,Chamomilla Recutita (Matricaria) Flower Extract,Tocopheryl Acetate,Citric Acid

Package Label Principal Display Panel

100 PCS IN 1 PAIL NDC: 78936-002-01


Structured Label Content

Use

Decreases bacteria on skin. Recommended for repeated use

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Purpose

Antiseptic

Warnings

For external use only. Flammable, keep product away from fire or flame.

Do not use over large areas of the body if you are allergic to any of the ingredients when using this product,avoid contact with eyes and face.If contact occurs,flush thoroughly with water.Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Directions

For adults and children of 2 years and over.children under 2 years ask a doctor before use.

Wet hands thoroughly with product and allow to dry without wiping.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Quaternary ammonium, Phenoxyethanol

Inactive Ingredients (Inactive ingredients)

Water,Glycerin,Polysorbate 20,Aloe Barbadensis Leaf Extract,Chamomilla Recutita (Matricaria) Flower Extract,Tocopheryl Acetate,Citric Acid

Package Label Principal Display Panel (Package Label - Principal Display Panel)

100 PCS IN 1 PAIL NDC: 78936-002-01


Advanced Ingredient Data


Raw Label Data

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