LIVE CLEAN BABY- 2% colloidal oatmeal cream
BELVEDERE INTERNATIONAL INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Fact

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 the eyes.Stop use and ask a doctor if condition w. orsens or does not improve within 7 days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

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

label

image description

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	01/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/20/2017	01/31/2023

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: 8/2023

Document Id: 0286044c-f854-2000-e063-6294a90a7281

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

Version: 3

Effective Time: 20230809

BELVEDERE INTERNATIONAL INC.