Label: HYALOLEX HAND SANITIZER WITH LEMON AND ZINC- alcohol solution
- NDC Code(s): 75540-536-02, 75540-536-08, 75540-536-16, 75540-536-28
- Packager: India Globalization Capital
- 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 19, 2023
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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
- Hyalolex Hand Sanitizer with Lemon and Zinc Safate and Paraben Free 70% Ethyl Alcohol Antimicrobial Kills Germs Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HYALOLEX HAND SANITIZER WITH LEMON AND ZINC
alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75540-536 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) 2 mL in 100 mL LEMON OIL (UNII: I9GRO824LL) 0.5 mL in 100 mL ZINC ALUM (UNII: UGR874142R) 20 mg in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 2 mL in 100 mL CARBOMER 980 (UNII: 4Q93RCW27E) 0.25 mL in 100 mL WATER (UNII: 059QF0KO0R) 25 mL in 100 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.25 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75540-536-02 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2020 2 NDC:75540-536-08 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2020 3 NDC:75540-536-16 472 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2020 4 NDC:75540-536-28 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/30/2020 Labeler - India Globalization Capital (364601877)