APRIL BATH AND SHOWER ANTI-BACTERIAL HAND 3 PACK- triclosan
Greenbrier 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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APRIL Bath & Shower Anti-bacterial Hand Lotions 3 Pack

APRIL Bath and Shower anti-bacterial hand lotion VANILLA BROWN SUGAR SCENTED
APRIL Bath and Shower anti-bacterial hand lotion JAPANESE BLOSSOM SCENTED
APRIL Bath and Shower anti-bacterial hand lotion CRANBERRY CHERRY SCENTED

Active Ingredient

Triclosan 0.15%

Purpose

Antiseptic

Uses

to decrease bacteria on skin

Warnings

For external use only

For adult use only

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation and redness develop.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

rub into hands

Inactive Ingredients

water, mineral oil, cetearyl alcohol, propylene glycol, PEG-100 Stearate, glyceryl stearate, carbomer, triethanolamine, fragrance, tocopheryl acetate, propylparaben, methylparaben, methylisothiazolinone, allantoin, disodium EDTA

APRIL Bath and Shower Anti-bacterial Hand Lotions 3 Pack (33992-0010-3)
APRIL Bath and Shower anti-bacterial hand lotion VANILLA BROWN SUGAR SCENTED 1oz/28.4g (33992-0011-0)
APRIL Bath and Shower anti-bacterial hand lotion JAPANESE BLOSSOM SCENTED 1oz/28.4g (33992-0012-0)
APRIL Bath and Shower anti-bacterial hand lotion CRANBERRY CHERRY SCENTED 1oz/28.4g (33992-0013-0)

Front

Back

Bottom

APRIL BATH AND SHOWER ANTI-BACTERIAL HAND 3 PACK
triclosan kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33992-0010

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-0010-3	1 in 1 KIT	06/06/2013	11/01/2015

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	28.4 g
Part 2	1 BOTTLE	28.4 g
Part 3	1 BOTTLE	28.4 g

Part 1 of 3

APRIL BATH AND SHOWER ANTI-BACTERIAL HAND VANILLA BROWN SUGAR SCENTED
triclosan lotion

Product Information
Item Code (Source)	NDC:33992-0011
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-0011-0	28.4 g in 1 BOTTLE; 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	part333E	06/06/2015	11/01/2015

Part 2 of 3

APRIL BATH AND SHOWER ANTI-BACTERIAL HAND JAPANESE BLOSSOM SCENTED
triclosan lotion

Product Information
Item Code (Source)	NDC:33992-0012
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-0012-0	28.4 g in 1 BOTTLE; 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	part333E	06/06/2013	11/01/2015

Part 3 of 3

APRIL BATH AND SHOWER ANTI-BACTERIAL HAND CRANBERRY CHERRY SCENTED
triclosan lotion

Product Information
Item Code (Source)	NDC:33992-0013
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.15 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-0013-0	28.4 g in 1 BOTTLE; 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	part333E	06/01/2015	11/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/06/2013	11/01/2015

Labeler - Greenbrier International, Inc. (610322518)

Name	Address	ID/FEI	Business Operations
Establishment
Lab Douce Cosmetics (Shenzhen) Co., Ltd.		529303186	manufacture(33992-0010, 33992-0011, 33992-0012, 33992-0013)

Revised: 11/2015

Document Id: 26355d86-4f80-6116-e054-00144ff88e88

Set id: 9d5d4975-6083-434a-b133-8d7573b736c8

Version: 3

Effective Time: 20151101

Greenbrier International, Inc.