Label: OLIKA HAND SANITIZER FRAGRANCE FREE- ethyl alcohol hand sanitizer liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76751-211-01, 76751-211-02, 76751-211-03 - Packager: Perkin and Perkin 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 December 20, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the 1994 tentative final monograph for hand sanitizers and antiseptics.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) or Food Chemical Codex (FCC) grade ingredients in the preparation of the product. Final formulation finished product testing was performed to confirm efficacy.
- Alcohol (ethanol) (USP) (65%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
The formulation comes in 3 package sizes 20 mL, 30 mL, and 90 mL.
- Active Ingredient(s)
- Purpose
- 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
- Other information
- Inactive ingredients
- Use
- Directions
- Information Panel
- 76751-211-01 Package Label - Principal Display Panel
- 76751-211-02 Package Label _Principal Display Panel
- 76751-211-03 Package Label_ Principal Display Panel
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INGREDIENTS AND APPEARANCE
OLIKA HAND SANITIZER FRAGRANCE FREE
ethyl alcohol hand sanitizer liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76751-211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 65 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 4.2 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.25 mL in 100 mL WATER (UNII: 059QF0KO0R) 30.55 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76751-211-01 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2020 2 NDC:76751-211-02 20 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2020 3 NDC:76751-211-03 90 mL in 1 POUCH; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/01/2020 Labeler - Perkin and Perkin LLC (080476192)
