Baby Mantra Diaper Rash Ointment

Baby Mantra Diaper Rash Ointment
SPL v2
SPL
SPL Set ID 0427bbc9-f4c0-0eb6-e063-6294a90a7199
Route
TOPICAL
Published
Effective Date 2024-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (10 g)
Inactive Ingredients
Almond Oil .alpha.-tocopherol, D- Glycerin Jojoba Oil White Wax Water Rosemary Sunflower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-03

Description

Active Ingredient Zinc Oxide 10%


Medication Information

Warnings and Precautions

Warnings: For external use only.

When using this product, do 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

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Uses:

  • Helps treat and prevent diaper rash.
  • Protects chafed skin due to diaper rash and helps protect skin from wetness.
  • Helps prevent and temporarily protects chafed, chapped, cracked or wind-burned skin and lips.
Dosage and Administration

Directions:

  • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
  • Apply ointment liberally, as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diaper
Description

Active Ingredient Zinc Oxide 10%

Section 43683-2

For Indications and Usage section : Not a major change - We have only updated our Effective Date.

For Dosage and Administration section: Not a major change - we have only updated our Effective Date.

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
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 50570-1

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns
Section 51727-6

Inactive Ingredients:

Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax (White), Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol (D-alpha), Aqua (Water), Glycerin

Section 51945-4

TUBE ARTWORK

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active Ingredient

Zinc Oxide 10%

Section 60561-8

Store at room temperature


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Helps treat and prevent diaper rash.
  • Protects chafed skin due to diaper rash and helps protect skin from wetness.
  • Helps prevent and temporarily protects chafed, chapped, cracked or wind-burned skin and lips.
Dosage and Administration (34068-7)

Directions:

  • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
  • Apply ointment liberally, as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diaper
Warnings and Precautions (34071-1)

Warnings: For external use only.

When using this product, do 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

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 43683-2 (43683-2)

For Indications and Usage section : Not a major change - We have only updated our Effective Date.

For Dosage and Administration section: Not a major change - we have only updated our Effective Date.

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
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 50570-1 (50570-1)

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns
Section 51727-6 (51727-6)

Inactive Ingredients:

Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax (White), Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol (D-alpha), Aqua (Water), Glycerin

Section 51945-4 (51945-4)

TUBE ARTWORK

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

Zinc Oxide 10%

Section 60561-8 (60561-8)

Store at room temperature


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)