Label: CLEAR DEFENSE CITRUS SAGE- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 54473-258-02 - Packager: Melaleuca Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 23, 2018
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- Active ingredient
- Purpose
- Uses
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEAR DEFENSE CITRUS SAGE
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-258 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) FERRIC OXIDE RED (UNII: 1K09F3G675) GLYCERIN (UNII: PDC6A3C0OX) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) POLYSORBATE 20 (UNII: 7T1F30V5YH) D&C RED NO. 30 (UNII: 2S42T2808B) SHEA BUTTER (UNII: K49155WL9Y) TALC (UNII: 7SEV7J4R1U) 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:54473-258-02 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 05/15/2014 Labeler - Melaleuca Inc (139760102) Registrant - Melaleuca Inc (079711683) Establishment Name Address ID/FEI Business Operations Melaleuca Inc 079711683 manufacture(54473-258)