Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID cdd4166e-058a-4819-bc79-b877e4e4f2f7
Route
TOPICAL
Published
Effective Date 2021-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (480 g)
Inactive Ingredients
Sunflower Oil Castor Oil Hydrogenated Palm Oil Cocoa Butter Cetyl Palmitate Shea Butter Coconut Oil Tamanu Oil .alpha.-tocopherol Acetate Starch, Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-02-01

Description

Zinc Oxide-40%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide-40%

Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness
Section 50565-1
  • Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9
  • 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
Section 50567-7
  • When using this product, do not get into eyes
Section 50570-1

Do not use if quality seal is broken

  • Do not store above 104°F/40°C
Section 51727-6

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

Warnings

For external use only

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
Active Ingredient

Zinc Oxide-40%

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

Structured Label Content

Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness
Section 50565-1 (50565-1)
  • Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9 (50566-9)
  • 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
Section 50567-7 (50567-7)
  • When using this product, do not get into eyes
Section 50570-1 (50570-1)

Do not use if quality seal is broken

  • Do not store above 104°F/40°C
Section 51727-6 (51727-6)

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

Purpose

Skin Protectant

Warnings

For external use only

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
Active Ingredient (Active ingredient)

Zinc Oxide-40%

Principal Display Panel – 118 Ml Carton Label (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)