COTTONWOOD SANITIZER  GEL - alcohol gel 
Alpine Distilling

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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Drug Facts

Active Ingredient(s):

Ethyl Alcohol 65% v/v

Purpose :

Antibacterial

Use(s):

For rinse free hand cleaning when soap and water are not available.

Warning:

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

When using this product: Avoid contact with eyes, ears and mouth. In case of eye contact, rinse 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 & pets. If swallowed, get medical help or contact a Poison Control Center Right away.

Directions:

Apply to dry hands, rub into skin, no rinsing required.

Other Information:

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

Inactive Ingredients:

Glycerin, Betaine, Polyacrylamide, Isoparaffin, Laureth-7, Purified Water USP, Fragrance

Manufactured by Cottonwood Spirits LLC – 7132 N Silver Creek Road, Park City Utah 84098

DUNS: 080985574 FDA/NDC: 78002

435-200-9537 info@alpinedistilling.com

Principal Display Panel – 500 mL Bottle Label

COTTONWOORD
HAND SANITIZER
WITH ESSENTIAL OILS

UNSCENTED

16 OZ – 500 mL

Principal Display Panel – 500 mL Bottle Label
COTTONWOOD SANITIZER   GEL
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78002-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Betaine (UNII: 3SCV180C9W)  
Polyacrylamide (Crosslinked; 0.01-0.2 Mole Percent Bisacrylamide) (UNII: RHA9LWJ494)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
Laureth-7 (UNII: Z95S6G8201)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78002-101-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
2NDC:78002-101-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
3NDC:78002-101-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
4NDC:78002-101-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/06/2020
Labeler - Alpine Distilling (080985574)
Establishment
NameAddressID/FEIBusiness Operations
Alpine Distilling080985574MANUFACTURE(78002-101)

Revised: 7/2020
Document Id: 6c40fff4-70b8-4016-aeaf-cb5aa2fff6d3
Set id: e964e970-bd09-4398-861a-3123372886ab
Version: 1
Effective Time: 20200706
 
Alpine Distilling