Label: MS. GERMSAFE ANTIBACTERIAL HAND SANITIZER -TROPICAL COCONUT- ethyl alcohol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 79774-002-02, 79774-002-03, 79774-002-05 - Packager: Germ Safe Company, Inc., The
- 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 January 27, 2022
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- Drug Facts
- Active ingredient
- Purpose
- INDICATIONS & USAGE
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Warnings
Flammable, keep away from fire/flame
For external use only
Do not use • in children less than 2 months of age • on open skin wounds.
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72hours.
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients water, fragrance, limonene, aloe vera (Aloe barbadensis) leaf extract, bronopol, dichlorobenzyl alcohol, linalool, hexyl cinnamal, lactic acid, phenoxyethanol, butylphenyl methylpropional, citric acid, caprylyl glycol, citronellol, vitamin E, sodium benzoate, benzyl alcohol, geraniol, citral, amyl cinnamal, benzyl benzoate, denatonium benzoate.
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
MS. GERMSAFE ANTIBACTERIAL HAND SANITIZER -TROPICAL COCONUT
ethyl alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79774-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LIMONENE, (+)- (UNII: GFD7C86Q1W) ALOE VERA LEAF (UNII: ZY81Z83H0X) BRONOPOL (UNII: 6PU1E16C9W) DICHLOROBENZYL ALCOHOL (UNII: 1NKX3648J9) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SODIUM BENZOATE (UNII: OJ245FE5EU) BENZYL ALCOHOL (UNII: LKG8494WBH) GERANIOL (UNII: L837108USY) CITRAL (UNII: T7EU0O9VPP) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) BENZYL BENZOATE (UNII: N863NB338G) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79774-002-02 98 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/07/2020 2 NDC:79774-002-03 148 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/07/2020 3 NDC:79774-002-05 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/07/2020 Labeler - Germ Safe Company, Inc., The (117574813)
