BABY DIAPER RASH- zinc oxide cream

BABY Diaper Rash by

Drug Labeling and Warnings

BABY Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Xtreme Tools International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide 17%

Purpose

Skin Protectant

Uses

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

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 day

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, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

• Store at 20° to 25°C (68° to 77°F)
• May stain clothing

Inactive ingredients

Water (Aqua), Vegetable Oil (Olus Oil in the EU), Butyrospermum parkii (Shea Butter) Fruit, Cocos Nucifera (Coconut) Oil, Glycerin, Vitis Vinifera (Grape) Seed Oil, Aloe Barbadensis Leaf Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Lavandula Angusfifolia (Lavender) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Anthemis Nobilis Flower extract, Shea Butter Ethyl Esters, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Hydrogenated Vegetable Oil, Heptyl Undecylenate, Polyglyceryl-2 Dipolyhydroxystearate, Cetearyl Alcohol, Polisorbate 60, Myrica Pubescens Fruit wax, Beeswax, Tocopheryl Acetate, Panthenol, Phenoxyethanol, Ethylhexylglycerin, Citric Acid

Questions or comments?

Call 1-305-622-7474, Monday through Friday 9:00 AM to 5:00 PM

Principal Display Panel

198 g in Jar; NDC: 74553-002-01

INGREDIENTS AND APPEARANCE

BABY DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74553-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
JOJOBA OIL (UNII: 724GKU717M)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALMOND OIL (UNII: 66YXD4DKO9)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
GLYCERIN (UNII: PDC6A3C0OX)
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
YELLOW WAX (UNII: 2ZA36H0S2V)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74553-002-01	198 g in 1 JAR; Type 0: Not a Combination Product	10/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/06/2020

Labeler - Xtreme Tools International, Inc (125398904)

Registrant - Xtreme Tools International, Inc (125398904)

Establishment
Name	Address	ID/FEI	Business Operations
Xtreme Tools International, Inc		125398904	manufacture(74553-002)