Members Mark Diaper Rash
FDA Label NDC 68196-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sams West Inc for the product Members Mark Diaper Rash (NDC 68196-002). 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 active ingredient, purpose, uses, warnings, when using this product, stop using this product and ask a doctor if, do not use on, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide 13%

Purpose

Skin protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash
  • helps seal out wetness

Warnings

For external use only.

When Using This Product

Do not get into eyes.

Stop Using This Product And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Do Not Use On

  • deep puncture wounds
  • animal bites
  • serious burns

Keep Out Of Reach Of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

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

Other Information

store between 20°C - 25°C (68°F - 77°F)

Inactive Ingredients

Water (Aqua), Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Aloe Barbadensis Leaf Juice, Glycerin, Tropolone, Tocopheryl Acetate, Panthenol, 1,2-Hexanediol, Caprylyl Glycol, Magnesium Sulfate, Potassium Hydroxide.

Questions Or Comments?

1-888-301-0332

Label Copy

Image Of The Label (13484l)

Image Of The Label (13484l)

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