Label: SHOWER POUCH CUCUMBER- isopropyl alcohol cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 77371-111-01 - Packager: NICETY SOLUTIONS LLC
- 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 July 20, 2022
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INGREDIENTS AND APPEARANCE
SHOWER POUCH CUCUMBER
isopropyl alcohol clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77371-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.75 mL in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) TEA TREE OIL (UNII: VIF565UC2G) MENTHOL (UNII: L7T10EIP3A) WILLOW BARK (UNII: S883J9JDYX) PANTHENOL (UNII: WV9CM0O67Z) WITCH HAZEL (UNII: 101I4J0U34) POLYSORBATE 20 (UNII: 7T1F30V5YH) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) TRIMETHYLENEDIAMINETETRAACETIC ACID (UNII: 3F6OA94EER) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77371-111-01 54 mL in 1 PACKET; Type 0: Not a Combination Product 05/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/05/2020 Labeler - NICETY SOLUTIONS LLC (030405122) Registrant - NICETY SOLUTIONS LLC (030405122)