Raw Sugar Hand Sanitizer, Peppermint and Sea Salt

Raw Sugar Hand Sanitizer Peppermint and Sea Salt by

Drug Labeling and Warnings

Raw Sugar Hand Sanitizer Peppermint and Sea Salt by is a Otc medication manufactured, distributed, or labeled by Bolero Home Decor, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RAW SUGAR HAND SANITIZER PEPPERMINT AND SEA SALT- alcohol gel 
Bolero Home Decor, Inc.

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.

----------

Raw Sugar Hand Sanitizer, Peppermint and Sea Salt

Drug Facts

Active ingredient

Ethyl Alcohol 62%

Purpose

Antimicrobial

Uses

  • Hand sanitizing to reduce bacteria on the skin that could cause disease 
  • Recommended for repeated use 

Warnings

Flammable. Keep away from fire or flame.
For external use only. Do not inhale or ingest.

Avoid contact with eyes. In case of eye contact, fush eyes with water.

Stop use and see a doctor if

  • irritation or redness develops 
  • condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly until dry
  • Children under the age of 6 should be supervised when using this product

Other Information

  • Store at 20-25°C (68-77°F) 
  • May discolor certain fabrics or surfaces.

Inactive Ingredients

Water (Aqua), Carbomer, Aminomethyl Propanol, Glycerin, *Mentha Piperita (Peppermint) Extract, Sodium Chloride (Sea Salt), *Aloe Barbadensis (Aloe Vera) Leaf Juice, *Zingiber Offfcinale (Ginger) Root Extract, *Symphytum Offcinale (Comfrey) Leaf Extract, *Hibiscus Sabdariffa Flower Extract, Fragrance (Parfum)) *Certifed Organic

Package Labeling:

Bottle2

RAW SUGAR HAND SANITIZER PEPPERMINT AND SEA SALT 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 57469-069
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHA X PIPERITA WHOLE (UNII: 79M2M2UDA9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GINGER (UNII: C5529G5JPQ)  
SYMPHYTUM X UPLANDICUM LEAF (UNII: D05HXK6R3G)  
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 57469-069-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/202010/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/01/202010/01/2022
Labeler - Bolero Home Decor, Inc. (067967365)

Revised: 10/2021
Document Id: cd88c548-6c04-c185-e053-2a95a90aba8f
Set id: b25c3bce-f7a2-7a30-e053-2995a90adde8
Version: 4
Effective Time: 20211004