Botao Baby Diaper Rash Cream
FDA Label NDC 69435-1501

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Peer Pharm Ltd. for the product Botao Baby Diaper Rash Cream (NDC 69435-1501). 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 drug facts, active ingredients(in each 30 ml), purpose, uses, warnings, do not use, when using this product,, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients(In Each 30 Ml)

Zinc Oxide 12%

Purpose

Sunscreen

Uses

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

Warnings

  • For external use only.

Do Not Use

  • on damaged or broken skin.

When Using This Product,

  • Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

  • if rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

If swallowed, call a poison control center or get medical help right  away.

Directions

Change Wet and Soiled Diapers Promptly

Cleanse the diaper area

Allow to dry

Apply cream liberally as often as necessary , with each diaper change , especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive Ingredients

Coconut Alkanes, Cocos Nucifera (Virgin Coconut) Oil, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Ricinus Communis (Castor) Seed Oil*, Ethyl Macadamiate, Shea Butter Ethyl Ester, Glycerin*, Polyglyceryl Esters, Polyhydroxystearic Acid, Citrus Aurantium Dulcis (Orange) Peel Wax, Simmondsia Chinensis (Jojoba) Seed Oil*, Jojoba Esters, Coco-Caprylate/Caprate, Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea Butter) Fruit*, Tocopherol (Vitamin E), Capric Acid, Silica, Disteardimonium Hectorite, Kaolin, Argania Spinosa (Argan) Kernel Oil, Rosa Canina Seed (Rosehip) Oil, Lavandula Angustifolia (Lavender) Oil, Olea Europaea (Olive) Oil, Origanum Vulgare (Oregano) Leaf Extract,
Tocopheryl Acetate, Basabolol, Malic Acid. May Contain: Iron Oxides.
*Certified Organic

Other Information

  • Store in room temparture
  • protect from freezing
  • may stain clothing

Package Labeling

Box (33371 Botao Diaper Rash Cream Box Fda 06)

Box (33371 Botao Diaper Rash Cream Box Fda 06)

* Please review the disclaimer below.