BABY MANTRA DIAPER CREAM- zinc oxide 10% ointment

Baby Mantra Diaper Cream by

Drug Labeling and Warnings

Baby Mantra Diaper Cream by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Zinc Oxide 10%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & 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.

WARNINGS

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.

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

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

DOSAGE & 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

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

Store at room temperature

PRINCIPAL DISPLAY PANEL

TUBE ARTWORK

INGREDIENTS AND APPEARANCE

BABY MANTRA DIAPER CREAM 
zinc oxide 10% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-825
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
JOJOBA OIL (UNII: 724GKU717M)
WHITE WAX (UNII: 7G1J5DA97F)
WATER (UNII: 059QF0KO0R)
ROSEMARY (UNII: IJ67X351P9)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-825-34	100 mL in 1 TUBE; Type 0: Not a Combination Product	01/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	01/03/2024

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-825)