April Bath And Shower Cucumber Melon Scented Hand Sanitizer Anti-bacterial
FDA Label NDC 50563-113

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Enchante Accessories Inc. for the product April Bath And Shower Cucumber Melon Scented Hand Sanitizer Anti-bacterial (NDC 50563-113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Chloroxylenol  0.5%

Otc - Purpose

Purpose

Antiseptic

Indications & Usage

Uses

To decrease bacteria on the skin that could cause diseases

Recommended for repeated use

Warnings

For external use only

Flammable

When using this product: Keep out of eyes. In case of contact with eyes, flush thoroughly with water.  Avoid Contact with broken skin. Do not inhale or ingest.


Otc - Ask Doctor

Stop use and ask a doctor if skin irritation develops

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away

Dosage & Administration

Directions

  • Wet hands thoroughly with product and allow to dry without wiping
  • For children under 6, use only under adult supervision
  • Not recommended for infants

Storage And Handling

Other Information:

  • Do not store above 105F
  • May discolor some fabrics
  • Harmful to wood finishes and plastics

Inactive Ingredient

Inactive Ingredient:

Benzethonium Chloride, Alcohol, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Tocopheryl Acetate, may contain D and C Red No. 33, D and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

Package Label.Principal Display Panel

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Label (Cucumber)

Label (Cucumber)

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