CRYSTAL RIDGE HAND SANITIZER- hand sanitizer liquid

Crystal Ridge Hand Sanitizer by

Drug Labeling and Warnings

Crystal Ridge Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Crystal Ridge Distillery. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 80 % v/v

PURPOSE

Antiseptic

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other Information:

Store between 15-30c (59-86F)

Avoid freezing and excessive heat above 40 C (104F)

INACTIVE INGREDIENT

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Hand Sanitizer

1. 750 mL size bottle NDC: 74207-010-07
   
2. Back Label
   

Hand Sanitizer

3.78 L plastic jug, NDC: 7207-010-40

Hand Sanitizer

18.9L bucket label with handwritten batch number included on bucket:

INGREDIENTS AND APPEARANCE

CRYSTAL RIDGE HAND SANITIZER 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74207-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	155 L  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74207-010-07	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2020
2	NDC: 74207-010-40	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2020
3	NDC: 74207-010-80	20000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/28/2020

Labeler - Crystal Ridge Distillery (029126883)

Establishment
Name	Address	ID/FEI	Business Operations
Crystal Ridge Distillery		029126883	manufacture(74207-010)