READY4LIFE HAND SANITIZER GEL WILDWOODS- alcohol liquid

Ready4Life Hand Sanitizer Gel Wildwoods by

Drug Labeling and Warnings

Ready4Life Hand Sanitizer Gel Wildwoods by is a Otc medication manufactured, distributed, or labeled by Hand 2 Hand Industries, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

1. 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.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. 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)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, water USP, carbomer, dimethicone, triethlyamine, fragrance

Package Label - Principal Display Panel

60 mL NDC: 78794-122-01

237 mL NDC: 78794-122-02

384 mL NDC: 78794-122-03

INGREDIENTS AND APPEARANCE

READY4LIFE HAND SANITIZER GEL WILDWOODS 
alcohol liquid

Product 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)