Triple 3x Max Diaper Rash Ointment
FDA Label NDC 16864-061

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advantice Health, Llc for the product Triple 3x Max Diaper Rash (NDC 16864-061). 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 other, active ingredient, purpose, uses, warnings, otc - when using, stop use and ask a doctor if, otc - 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

Other

Drug Facts

Distributed by Advantice Health, LLC
Bridgewater, NJ 08807

Active Ingredient

Zinc oxide 40%

Purpose

Skin protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect from wetness

Warnings

For external use only

Otc - When Using

When using this productdo not get into eyes.

Stop Use And Ask A Doctor If

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

Directions

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

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

avena sativa (oat) kernel extract, beeswax, bisabolol, cholesterol, glycerin, lanolin, mineral oil, water, white petrolatum, zea mays (corn) starch

Questions?

1-800-345-0032

Principal Display Panel - 57 G Tube Carton

PEDIATRICIAN RECOMMENDED

TRIPLE PASTE ®

40% Zinc Oxide / Skin Protectant

ACCEPTED
e
National
Eczema
Association

Diaper Rash Relief
3X* MAX
3X ZINC OXIDE

PLUS SKIN NOURISHING
INGREDIENTS

  • Oat Extract
  • Beeswax
  • Glycerin

    • Fragrance Free • Hypoallergenic • Talc Free

    Prevents • Treats • Soothes

    Net Wt. 2oz. (57g)

    Principal Display Panel (57 g Tube Carton)

    Principal Display Panel (57 g Tube Carton)

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