Being Well Diaper Rash Creamy
FDA Label NDC 68169-3229

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tai Guk Pharm. Co., Ltd. for the product Being Well Diaper Rash Creamy (NDC 68169-3229). 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, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, 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                                                                        Purpose

Zinc oxide 10% ........................................................................ Skin protectant         

Otc - Purpose

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness
  • helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use over deep or puncture wounds, infections or lacerations

Otc - When Using

When using this product avoid contact with the eyes

Otc - Stop Use

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Otc - 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

Indications & Usage

Directions

  • change wet and soiled diapers promptly, cleanse the diaper area and allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Storage And Handling

Other information

  • store at room temperature
  • Lot No and Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

White petrolatum, talc, purified lanolin, liquid paraffin, triethanolamine, aloe vera gel, tocopherol acetate, butylated hydroxyloluene, methyl parahydroxybenzoate, purified water

Dosage & Administration

Distributed by: Preferred Products, Inc.

                      Earth City, MO 63045


Product of Korea


Package Label.Principal Display Panel

Image Of Carton Label (Beingwelldiaperrash)

Image Of Carton Label (Beingwelldiaperrash)

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