WHITE LAVENDER AND MINT ANTIBACTERIAL MOISTURIZING HAND SP: Package Insert and Label Information

WHITE LAVENDER AND MINT ANTIBACTERIAL MOISTURIZING HAND SP — triclosan liquid
H E B

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.

ACTIVE INGREDIENT

TRICLOSAN 0.3 PERCENT

PURPOSE

ANTIBACTERIAL

USES

TO HELP REDUCE BACTERIA ON THE SKIN.

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 AND 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, GLYCERETH-26, COCO-GLUCOSIDE, GLYCERYL OLEATE, LAURYL LACTYL LACTATE, GLYCERYL STEARATE, LAVENDULA ANGUSTIFOLIA (LAVENDER) FLOWER/LEAF/STEM EXTRACT, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, TOCOPHERYL ACETATE, BENZOPHENONE-4, DISODIUM EDTA, SODIUM HYDROXIDE, CITRIC ACID, BENZYL ALCOHOL, FRAGRANCE, MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, IRON OXIDES (CI 77491), EXT. VIOLET 2 (CI 60730), RED 33 (CI 17200), METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE.

WHITE LAVENDER AND MINT ANTIBACTERIAL MOISTURIZING HAND SP triclosan liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-292 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (TRICLOSAN) TRICLOSAN 0.3 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER AMMONIUM LAURYL SULFATE CARBOMER COPOLYMER TYPE A COCAMIDOPROPYL BETAINE GLYCOL DISTEARATE GLYCERIN SODIUM CHLORIDE GLYCERETH-26 COCO GLUCOSIDE GLYCERYL MONOOLEATE LAURYL LACTATE GLYCERYL MONOSTEARATE LAVANDULA ANGUSTIFOLIA FLOWERING TOP MENTHA PIPERITA LEAF .ALPHA.-TOCOPHEROL ACETATE, D- SULISOBENZONE EDETATE DISODIUM SODIUM HYDROXIDE ANHYDROUS CITRIC ACID BENZYL ALCOHOL MANNITOL POWDERED CELLULOSE HYPROMELLOSES FERRIC OXIDE RED EXT. D&C VIOLET NO. 2 D&C RED NO. 33 METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:37808-292-08 236 mL in 1 BOTTLE, PUMP None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/30/2010

Labeler — H E B (007924756)

Registrant — APOLLO HEALTH AND BEAUTY CARE (201901209)

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

Revised: 01/2011 H E B