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NDC 60742-0005-01 LIVE CLEAN BABY 2 g/100g Details

LIVE CLEAN BABY 2 g/100g

LIVE CLEAN BABY is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by BELVEDERE INTERNATIONAL INC.. The primary component is OATMEAL.

Product Information

NDC	60742-0005
Product ID	60742-005_e1eaca0d-e22e-499f-89fc-e4802bd11a8e
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	LIVE CLEAN BABY
Proprietary Name Suffix	n/a
Non-Proprietary Name	2% COLLOIDAL OATMEAL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	2
Active Ingredient Units	g/100g
Substance Name	OATMEAL
Labeler Name	BELVEDERE INTERNATIONAL INC.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2022-12-31

Package

Package Images

NDC 60742-0005-01 (60742000501)

Pricing Information	N/A
NDC Package Code	60742-005-01
Billing NDC	60742000501
Package	170 g in 1 TUBE (60742-005-01)
Marketing Start Date	2017-07-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 408e36a9-118f-414f-a203-cd8560d19250 Details

uses

uses: Helps relieve minor skin irritation and itching due to: ■ Eczema ■ Rashes ■ Dry skin

Directions

DIRECTIONS■ Apply liberally over affected area as needed.

Inactive ingredients

loe Barbadensis Leaf Extract*, Avena Sativa (Oat) Kernel Extract*, Avena Sativa (Oat) Kernel Oil, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract*, Citric Acid, Cocoglycerides, Ethylhexylglycerin, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Glyceryl Stearate, Hydrogenated Vegetable Oil, Phenoxyethanol, Sodium Benzoate, Sodium Stearoyl Glutamate, Stearyl Alcohol, Vegetable Oil, Water, Xanthan gum

Active Ingredient

Colloidal Oatmeal 2.0% -------------------------------------------------------------							Skin Protectant

Keep out of reach of children

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

Warnings: For external use only.
When using this product avoid contact with eyes
Stop use and ask a doctor if condition worsens or does not improve within 7 days.
Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center immediately.

Uses

Uses: Helps relieve minor skin irritation and itching due to: ■ Eczema ■ Rashes ■ Dry skin

label

INGREDIENTS AND APPEARANCE

LIVE CLEAN BABY

2% colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60742-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
OAT KERNEL OIL (UNII: 3UVP41R77R)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60742-005-01	170 g in 1 TUBE; Type 0: Not a Combination Product	07/20/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/20/2017

Labeler - BELVEDERE INTERNATIONAL INC. (247836356)

Registrant - BELVEDERE INTERNATIONAL INC. (247836356)

Name	Address	ID/FEI	Business Operations
Establishment
BELVEDERE INTERNATIONAL INC.		247836356	manufacture(60742-005)

Revised: 7/2017

Document Id: e1eaca0d-e22e-499f-89fc-e4802bd11a8e

Set id: 408e36a9-118f-414f-a203-cd8560d19250

Version: 1

Effective Time: 20170720