RAW SUGAR HAND SANITIZER- PEPPERMINT AND SEA SALT.- alcohol gel

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., Product Packaging West, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient:

Organic 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.

Avoid contact with eyes.

In case of eye contact, flush eyes with water.

Stop use and see a doctor if

irritation or redness develops, or if condition persist for more than 72 hours.

Keep out of reach of childre.

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

Directions

• ​Place enough product in your palm to throughly 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 ​0C (68-77 ​0F)
• May discolor certain fabrics or surfaces.

Inactive Ingredients

Purified Water (Agua), Aminomethyl Propanol, Carbomer, Fragrance (Parfum), Polysorbate 20, Cocos Nucifera (Coconut) Fruit Extract*, Citrus Limon (Lemon) Fruit Extract*, Verbena Officinalis (Ginger) Root Extract*, Symphytum Officinale Extract*, Hibiscus Sabdariffa Flower Extract*.

*Certified Organic.

Raw Sugar Hand Sanitizer- Peppermint and Sea Salt.

INGREDIENTS AND APPEARANCE

RAW SUGAR HAND SANITIZER- PEPPERMINT AND SEA SALT. 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57469-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57469-065-01	266 mL in 1 PACKAGE; Type 0: Not a Combination Product	09/23/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/23/2016

Labeler - Bolero Home Decor, Inc. (009777118)

Registrant - Bolero Home Decor, Inc. (009777118)

Establishment
Name	Address	ID/FEI	Business Operations
Product Packaging West, Inc.		847033677	manufacture(57469-065)