CRYSTAL RIDGE HAND SANITIZER- hand sanitizer liquid 
Crystal Ridge Distillery

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.

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Hand sanitizer

Alcohol 80 % v/v

Antiseptic

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

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

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.

Directions:

Other Information:

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

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

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Hand Sanitizer

  1. 750 mL size bottle NDC 74207-010-07
    750 ml bottle
  2. Back Label
    Back Label with handwritten batch number added

Hand Sanitizer

Back label with handwritten batch number3.78 L jug

3.78 L plastic jug, NDC 7207-010-40

Hand Sanitizer

18.9L Bucket18.9L bucket label with handwritten batch number included on bucket:

CRYSTAL RIDGE HAND SANITIZER 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74207-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74207-010-07750 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/2020
2NDC:74207-010-403800 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/2020
3NDC:74207-010-8020000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/28/2020
Labeler - Crystal Ridge Distillery (029126883)
Establishment
NameAddressID/FEIBusiness Operations
Crystal Ridge Distillery029126883manufacture(74207-010)

Revised: 3/2020
Document Id: a7c166a0-9ca4-3346-e053-2995a90a256e
Set id: a1eeaea0-8cd7-1f17-e053-2a95a90aec27
Version: 1
Effective Time: 20200328
 
Crystal Ridge Distillery