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NDC 69435-1501-02 Botao Baby Diaper Rash Cream 9 g/71g Details

Botao Baby Diaper Rash Cream 9 g/71g

Botao Baby Diaper Rash Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Peer Pharm Ltd.. The primary component is ZINC OXIDE.

Product Information

NDC	69435-1501
Product ID	69435-1501_df60a70e-e6c1-41b3-e053-2995a90af176
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Botao Baby Diaper Rash Cream
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	9
Active Ingredient Units	g/71g
Substance Name	ZINC OXIDE
Labeler Name	Peer Pharm Ltd.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69435-1501-02 (69435150102)

Pricing Information	N/A
NDC Package Code	69435-1501-2
Billing NDC	69435150102
Package	1 TUBE, WITH APPLICATOR in 1 BOX (69435-1501-2) / 70.8 g in 1 TUBE, WITH APPLICATOR (69435-1501-1)
Marketing Start Date	2022-05-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL df60a70e-e6c0-41b3-e053-2995a90af176 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/19/2022

Labeler - Peer Pharm Ltd. (514678390)

Registrant - Peer Pharm Ltd. (514678390)

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

Revised: 5/2022

Document Id: df60a70e-e6c1-41b3-e053-2995a90af176

Set id: df60a70e-e6c0-41b3-e053-2995a90af176

Version: 1

Effective Time: 20220519