Zinc Oxide
FDA Label NDC 73418-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unconditional Love D/b/a Hello Bello for the product Zinc Oxide (NDC 73418-010). 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, otc - do not use, warnings, otc - when using, otc - stop use, 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

Active Ingredient

Zinc Oxide-40%

Purpose

Skin Protectant

Uses

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

Otc - Do Not Use

Do not use if quality seal is broken

  • Do not store above 104°F/40°C

Warnings

For external use only

Otc - When Using

  • When using this product, do not get into eyes

Otc - Stop Use

  • Stop use and ask a doctor if condition worsens or 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 to dry
  • Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive Ingredient

Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil*, Hydrogenated Palm Oil**, Theobroma Cacao (Cocoa) Seed Butter**, Cetyl Palmitate**, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Calophyllum Inophyllum Seed Oil, Tocopherol, Zea Mays (Corn) Starch*

*Organic **RSPO Certified

Principal Display Panel – 118 Ml Carton Label

Skin Protectant

hello
bello™

Made with sunflower seed,
coconut, and tamanu oils

Soothing Relief
Zinc Oxide Treatment

Diaper Rash
Cream

NET WT 4.0 fl. oz. (118ml) e

  • Hypoallergenic
  • Non-Nano Zinc Oxide
  • Pediatrician Tested
    Principal Display Panel – 118 mL Carton Label (Hel02 0000 01)

    Principal Display Panel – 118 mL Carton Label (Hel02 0000 01)

* Please review the disclaimer below.