PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER- alcohol gel

PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER by

Drug Labeling and Warnings

PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by SOMBRA COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

To decrease bacteria and viruses on the skin that could cause disease

Warnings

Flammable. Keep away from fire or flame. For external use only:  hands.

Do not use

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

When using this product

Keept out of the eyes.  In case of contact with eyes, flush shoroughly with water.  Avoid contact with broke skin.  Do not inhale or ingest.

Stop use and ask a doctor

Stop use and ask a doctor if irritation or rash appears and lasts.  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

Wet hands thoroughly with product and allow to dry without wiping.  For children under 6, use only under adult supervision.  Not recommended for infants.

Other Information

Do not store above 105F.  May discolor some fabrics.  May harm wood finishes.

Inactive ingredients

Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel
Oil, Citrus Limon (Lemon) Peel Oil, Filipendula Ulmaria, (Queen of the Prairie) Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Isopropyl Alcohol, Purified Water, Rosa Damascena Flower Water, Yucca Schidigera Stem Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-1118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
ORANGE PEEL (UNII: TI9T76XD44)
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
FILIPENDULA ULMARIA WHOLE (UNII: 3LH0M209LN)
GLYCERIN (UNII: PDC6A3C0OX)
WITCH HAZEL (UNII: 101I4J0U34)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-1118-8	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2020
2	NDC: 61577-1118-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2020
3	NDC: 61577-1118-6	474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/16/2020

Labeler - SOMBRA COSMETICS (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
SOMBRA COSMETICS		097464309	manufacture(61577-1118) , label(61577-1118)