CLEAR DEFENSE MAUI MELON- ethyl alcohol gel

Clear Defense by

Drug Labeling and Warnings

Clear Defense by is a Otc medication manufactured, distributed, or labeled by Melaleuca Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl alcohol 62%

Purpose

Antimicrobial

Uses

■ for handwashing to reduce bacteria on the skin

■ recommended for repeated use

WARNINGS

Warnings: For external use only

DO NOT USE

Do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions ■ place enough product in your palm to thoroughly cover your hands ■ rub hands together briskly until dry ■ children under 6 years of age should be supervised when using this product

STORAGE AND HANDLING

Other information ■ store below 82°F (28°C) ■ may discolor certain fabrics or surfaces ■ alcohol derived from corn

INACTIVE INGREDIENT

Inactive ingredients water, gylcerin, xylitol, anhydroxylitol, xylitylglucoside, carbomer, aminomethyl propanol, fragrance, aloe barbadensis leaf extract, melaleuca alternifolia leaf oil, polysorbate 20, tocopheryl acetate, jojoba esters, butyrospermum parkii, theobroma cacao seed butter, mangifera indica seed butter, blue 1 lake, titanium dioxide, yellow 5 lake

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEAR DEFENSE  MAUI MELON
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-271
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	36.58 g  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
COCOA BUTTER (UNII: 512OYT1CRR)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SHEA BUTTER (UNII: K49155WL9Y)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TEA TREE OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-271-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2018

Labeler - Melaleuca Inc (139760102)

Registrant - Melaleuca Inc (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca Inc		079711683	manufacture(54473-271)