SOMBRA ANTIBACTERIAL HAND SANITIZER- alcohol gel

SOMBRA ANTIBACTERIAL HAND SANITIZER by

Drug Labeling and Warnings

SOMBRA 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 Ingredients

Ethyl Alcohol 65% v/v

Uses

To decrease bacteria and viruses on the skin that could cause disease.  Recommended for repeated use.

Warnings

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

Do not use

avoid contact with broken skin. Do not inhale or ingest.  Children under 6, use only
under adult supervision.  Not recommended for infants.

When Using

When using this product, keep out of the eyes. In case of contact with eyes, flush thoroughly with water.

STOP USE

Stop use if irritation and redness develop or if 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.

Storage and Handling

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

Inactive ingredients

glycerin, purified water, isopropyl alcohol, aminomethyl propanol, citrus limon (lemon) peel oil, citrus aurantium dulcis (orange) peel oil, yucca schidigera stem extract,  rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, filipendula ulmaria (queen of the prairie) extract, camellia sinensis (green tea) leaf extract, aloe barbadensis leaf extract.

Purpose

Antiseptic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOMBRA ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-4130
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LEMON PEEL (UNII: 72O054U628)
ORANGE OIL (UNII: AKN3KSD11B)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
WITCH HAZEL (UNII: 101I4J0U34)
YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)
FILIPENDULA ULMARIA WHOLE (UNII: 3LH0M209LN)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-4130-1	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2020
2	NDC: 61577-4130-6	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/29/2020
3	NDC: 61577-4130-8	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/29/2020

Labeler - SOMBRA COSMETICS (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
SOMBRA COSMETICS		097464309	manufacture(61577-4130)