VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL MOISTURIZING HAND SP - triclosan liquid
HEB

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 FACTS

ACTIVE INGREDIENT

TRICLOSAN 0.3 PERCENT

PURPOSE

ANTIBACTERIAL

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION OR REDNESS DEVELOPS OR LASTS.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

APPLY TO WET HANDS, LATHER AND RINSE THOROUGHLY.

QUESTIONS OR COMMENTS

1-866-695-3030

INACTIVE INGREDIENTS

WATER, AMMONIUM LAURYL SULFATE, ACRYLATES COPOLYMER, COCAMIDOPROPYL BETAINE, GLYCOL DISTEARATE, GLYCERIN, SODIUM CHLORIDE, GYCERETH-26, COCO-GLUCOSIDE, GLYCERYL OLEATE, LAURYL LACTYL LACTATE, GLYCERYL STERATE, VANILLA PLANIFOLIA FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, TOCOPHERYL ACETATE, BENZOPHENONE-4, DISODIUM EDTA, SODIUM HYDROXIDE, CITRIC ACID, BENZYL ALCOHOL, FRAGRANCE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), RED 33 (CI 17200), METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE.

USES

To help reduce bacteria on the skin.

IMAGE OF VANILLA CREAM AND APPLE BLOSSOM HAND SANITIZER

VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL MOISTURIZING HAND SP
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37808-289
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERETH-26 (UNII: NNE56F2N14)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL MONOOLEATE (UNII: 4PC054V79P)
LAURYL LACTATE (UNII: G5SU0BFK7O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
VANILLA (UNII: Q74T35078H)
APPLE (UNII: B423VGH5S9)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SULISOBENZONE (UNII: 1W6L629B4K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37808-289-08	236 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/23/2010

Labeler - HEB (007924756)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture