Label: REVIVE HAND SANITIZER - PROTECT- alcohol spray
REVIVE HAND SANITIZER - IMMUNITY BOOST- alcohol spray
REVIVE HAND SANITIZER - LAVENDER- isopropyl alcohol hand sanitizer spray
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Contains inactivated NDC Code(s)
NDC Code(s): 78266-007-01, 78266-008-01, 78266-009-01 - Packager: TKS Co-Pack Manufacturing
- 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 23, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Ethyl Alcohol (75%, v/v) in an aqueous solution denatured to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
- Essential oil as fragrance (5.0% v/v)
- 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
REVIVE HAND SANITIZER - PROTECT
alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78266-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 22.5 mL in 30 mL Inactive Ingredients Ingredient Name Strength CINNAMON BARK OIL (UNII: XE54U569EC) 0.535 mL in 30 mL CLOVE OIL (UNII: 578389D6D0) 0.322 mL in 30 mL GLYCERIN (UNII: PDC6A3C0OX) 0.623 mL in 30 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.05 mL in 30 mL WATER (UNII: 059QF0KO0R) 5.219 mL in 30 mL CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q) 0.267 mL in 30 mL EUCALYPTUS OIL (UNII: 2R04ONI662) 0.267 mL in 30 mL ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L) 0.267 mL in 30 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78266-009-01 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 12/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/23/2020 REVIVE HAND SANITIZER - IMMUNITY BOOST
alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78266-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 22.5 mL in 30 mL Inactive Ingredients Ingredient Name Strength CINNAMON BARK OIL (UNII: XE54U569EC) 0.322 mL in 30 mL CLOVE OIL (UNII: 578389D6D0) 0.322 mL in 30 mL GLYCERIN (UNII: PDC6A3C0OX) 0.623 mL in 30 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.05 mL in 30 mL WATER (UNII: 059QF0KO0R) 5.217 mL in 30 mL CITRUS LIMON SEED OIL (UNII: T78Z8273XO) 0.322 mL in 30 mL EUCALYPTUS OIL (UNII: 2R04ONI662) 0.322 mL in 30 mL ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L) 0.322 mL in 30 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78266-007-01 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 12/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/23/2020 REVIVE HAND SANITIZER - LAVENDER
isopropyl alcohol hand sanitizer sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78266-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 22.5 mL in 30 mL Inactive Ingredients Ingredient Name Strength LAVENDER OIL (UNII: ZBP1YXW0H8) 1.6 mL in 30 mL GLYCERIN (UNII: PDC6A3C0OX) 0.62 mL in 30 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.05 mL in 30 mL WATER (UNII: 059QF0KO0R) 5.2 mL in 30 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78266-008-01 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 12/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/23/2020 Labeler - TKS Co-Pack Manufacturing (117172434) Registrant - TKS Co-Pack Manufacturing (117172434) Establishment Name Address ID/FEI Business Operations TKS Co-Pack Manufacturing 117172434 manufacture(78266-007, 78266-008, 78266-009)
