Label: PURE GENEX HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79654-002-01, 79654-002-02, 79654-002-03, 79654-002-04 - Packager: Enor International Inc.
- Category: HUMAN OTC DRUG LABEL
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 August 10, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
PURE GENEX HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79654-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) PANTHENOL (UNII: WV9CM0O67Z) TOCOPHEROL (UNII: R0ZB2556P8) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79654-002-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:79654-002-02 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 3 NDC:79654-002-03 250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/30/2020 4 NDC:79654-002-04 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Enor International Inc. (826315959) Establishment Name Address ID/FEI Business Operations Zhejiang Ushas Cosmetics Ltd. 544910474 manufacture(79654-002)