BODYCOLOGY ENCHANTED FOREST KIT- enchanted forest kit

Bodycology by

Drug Labeling and Warnings

Bodycology by is a Otc medication manufactured, distributed, or labeled by Advanced Beauty Systems, Inc., Landy International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Ethyl Alcohol 75% Antiseptic

Uses To decrease bacteria on the skin.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Stop use and consult doctor if irritation and redness develop and persist for more than 72 hours.

Warnings

For external use only.

FLAMMABLE. Keep away from heat and flame.

When using this product

-Avoid contact with eyes. If contact occurs, flush eyes with water.

-Avoid contact with broken skin.

Directions

-Wet hands with product.

-Briskly rub hands together until dry.

-For children under 6, use only under adult supervision.

-Not recommended for infants.

Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Ultramarines (CI 77007).

May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200).

PRINCIPAL DISPLAY PANEL

Bodycology

Moisturizing Hand Sanitizer

with Aloe Vera

kills 99% of germs without water

Enchanted Forest

30 mL 1 Fl Oz

INGREDIENTS AND APPEARANCE

BODYCOLOGY  ENCHANTED FOREST KIT
enchanted forest kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51345-061

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51345-061-01	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	30 mL
Part 2	1 BOTTLE	177 mL
Part 3	1 BOTTLE	118 mL
Part 4	1 BOTTLE	70 g

Part 1 of 4

BODYCOLOGY  ENCHANTED FOREST
ethyl alcohol gel

Product Information
Item Code (Source)	NDC: 51345-062
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	22.5 mL  in 22.5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
GELATIN (UNII: 2G86QN327L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ULTRAMARINE BLUE (UNII: I39WR998BI)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51345-062-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/30/2012

Part 2 of 4

BODYCOLOGY  FOAMING BODY WASH
body and hand (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	HONEY (UNII: Y9H1V576FH)
INGR	GLYCOL DISTEARATE (UNII: 13W7MDN21W)
INGR	COCO MONOETHANOLAMIDE (UNII: C80684146D)
INGR	LAURETH-10 (UNII: BD7AST04GA)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	SULISOBENZONE (UNII: 1W6L629B4K)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
INGR	FD&C RED NO. 4 (UNII: X3W0AM1JLX)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		177 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		06/30/2012

Part 3 of 4

BODYCOLOGY  FRAGRANCE MIST
other fragrance preparations

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	WATER (UNII: 059QF0KO0R)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SULISOBENZONE (UNII: 1W6L629B4K)
INGR	FD&C RED NO. 4 (UNII: X3W0AM1JLX)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		07/15/2012

Part 4 of 4

BODYCOLOGY  BODY BUTTER
body and hand (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	SOYBEAN OIL (UNII: 241ATL177A)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	COCOA BUTTER (UNII: 512OYT1CRR)
INGR	.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		70 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		08/07/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/03/2012

Labeler - Advanced Beauty Systems, Inc. (129986613)

Registrant - Advanced Beauty Systems, Inc. (129998613)

Establishment
Name	Address	ID/FEI	Business Operations
Landy International		545291775	manufacture(51345-061, 51345-062)