Label: READY4LIFE HAND SANITIZER GEL WILDWOODS- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78794-125-01, 78794-125-02, 78794-125-03 - Packager: Hand 2 Hand Industries, 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 October 2, 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:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according 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.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- 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
READY4LIFE HAND SANITIZER GEL WILDWOODS
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78794-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 73.0166 mL in 100 mL Inactive Ingredients Ingredient Name Strength CITRAL (UNII: T7EU0O9VPP) 0.00155 mL in 100 mL DIHYDRO PENTAMETHYLINDANONE (UNII: BZR4438MY4) 0.00155 mL in 100 mL DIHYDROMYRCENOL (UNII: 46L1B02ND9) 0.00155 mL in 100 mL LAVANDIN OIL (UNII: 9RES347CKG) 0.00155 mL in 100 mL ROSEMARY OIL (UNII: 8LGU7VM393) 0.00155 mL in 100 mL 2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE (UNII: 452GFV2AFS) 0.00155 mL in 100 mL BENZYL BENZOATE (UNII: N863NB338G) 0.00155 mL in 100 mL GERANYL ACETATE (UNII: 3W81YG7P9R) 0.00155 mL in 100 mL HEXYL ACETATE (UNII: 7U7KU3MWT0) 0.00155 mL in 100 mL PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 0.0666 mL in 100 mL TRIETHYLAMINE (UNII: VOU728O6AY) 0.134 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1.25 mL in 100 mL CARBOMER 980 (UNII: 4Q93RCW27E) WATER (UNII: 059QF0KO0R) ISOBORNYL ACETATE (UNII: 54T6CCU09Z) 0.00155 mL in 100 mL HEXAMETHYLINDANOPYRAN (UNII: 14170060AT) 0.00155 mL in 100 mL GERANIOL (UNII: L837108USY) 0.00155 mL in 100 mL VANILLIN (UNII: CHI530446X) 0.00155 mL in 100 mL BENZYL SALICYLATE (UNII: WAO5MNK9TU) 0.00155 mL in 100 mL LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.00155 mL in 100 mL COUMARIN 521 (UNII: 2773GTW04S) 0.00155 mL in 100 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.00155 mL in 100 mL .ALPHA.-DAMASCONE (UNII: UP5JTZ982I) 0.00155 mL in 100 mL 1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y) 0.00155 mL in 100 mL BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.00155 mL in 100 mL BORNEOL, (-)- (UNII: 1Y84986J9Q) 0.00155 mL in 100 mL ISOAMYL SALICYLATE (UNII: M25E4ZMR0N) 0.00155 mL in 100 mL CAMPHOR (NATURAL) (UNII: N20HL7Q941) 0.00155 mL in 100 mL LINALYL ACETATE, (-)- (UNII: J7C5I8LV3G) 0.00155 mL in 100 mL METHYL BENZODIOXEPINONE (UNII: 0NQ136C313) 0.00155 mL in 100 mL EUCALYPTUS OIL (UNII: 2R04ONI662) 0.00155 mL in 100 mL METHYL 3-METHYLORSELLINATE (UNII: 12YH9T04QE) 0.0031 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78794-125-01 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/09/2020 2 NDC:78794-125-02 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/09/2020 3 NDC:78794-125-03 384 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/09/2020 Labeler - Hand 2 Hand Industries, LLC (117545800) Establishment Name Address ID/FEI Business Operations Hand 2 Hand Industries, LLC 117545800 manufacture(78794-125)
