BOTAO BABY DIAPER RASH CREAM- zinc oxide cream

Botao Baby Diaper Rash Cream by

Drug Labeling and Warnings

Botao Baby Diaper Rash Cream by is a Otc medication manufactured, distributed, or labeled by Peer Pharm Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients(in each 30 ml)

Zinc Oxide 12%

Purpose

Sunscreen

Uses

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

warnings

• For external use only.

Do not use

• on damaged or broken skin.

When using this product,

• Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

• if rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, call a poison control center or get medical help right  away.

Directions

Change Wet and Soiled Diapers Promptly

Cleanse the diaper area

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.

Inactive Ingredients

Coconut Alkanes, Cocos Nucifera (Virgin Coconut) Oil, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Ricinus Communis (Castor) Seed Oil*, Ethyl Macadamiate, Shea Butter Ethyl Ester, Glycerin*, Polyglyceryl Esters, Polyhydroxystearic Acid, Citrus Aurantium Dulcis (Orange) Peel Wax, Simmondsia Chinensis (Jojoba) Seed Oil*, Jojoba Esters, Coco-Caprylate/Caprate, Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea Butter) Fruit*, Tocopherol (Vitamin E), Capric Acid, Silica, Disteardimonium Hectorite, Kaolin, Argania Spinosa (Argan) Kernel Oil, Rosa Canina Seed (Rosehip) Oil, Lavandula Angustifolia (Lavender) Oil, Olea Europaea (Olive) Oil, Origanum Vulgare (Oregano) Leaf Extract,
Tocopheryl Acetate, Basabolol, Malic Acid. May Contain: Iron Oxides.
*Certified Organic

Other Information

• Store in room temparture
• protect from freezing
• may stain clothing

Package Labeling

INGREDIENTS AND APPEARANCE

BOTAO BABY DIAPER RASH CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	9 g  in 71 g

Inactive Ingredients
Ingredient Name	Strength
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALGINIC ACID (UNII: 8C3Z4148WZ)
ALOE (UNII: V5VD430YW9)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL 1-PHOSPHATE (UNII: 48G71659RB)
CHAMOMILE (UNII: FGL3685T2X)
.BETA.-BISABOLOL (UNII: LP618AV2EA)
XANTHAN GUM (UNII: TTV12P4NEE)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1501-2	1 in 1 BOX	05/19/2022
1	NDC: 69435-1501-1	70.8 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	05/19/2022

Labeler - Peer Pharm Ltd. (514678390)

Registrant - Peer Pharm Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharm Ltd.		514678390	manufacture(69435-1501)