SOMBRA HAND SANITZER- alcohol spray 
SOMBRA COSMETICS

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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Sombra Hand Sanitizer

Active Ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

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

Warnings

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

Do not use

Stop use and ask doctor if, irritation and redness develop condition persists for more than 72 hours.

When using this product

When using this product, keep out of the eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor

Stop use and ask doctor if, irritation and redness develop 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 juice, Citrus Aurantium Dulce (orange) Peel Oil, Glycerin, Isopropyl Alcohol, Purified Water, Rosa Damascena Flower Water, Hamemelis Viginiara Leaf Extract, Yucca Schidigera Root Extract.

image description

SOMBRA HAND SANITZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-4129
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ORANGE PEEL (UNII: TI9T76XD44)  
GLYCERIN (UNII: PDC6A3C0OX)  
WITCH HAZEL (UNII: 101I4J0U34)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-4129-2118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/22/2020
Labeler - SOMBRA COSMETICS (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS097464309manufacture(61577-4129) , label(61577-4129)

Revised: 7/2020
Document Id: 9ebfbea5-bbbd-4de0-b41f-71e5a99feae4
Set id: d9dad29c-ab17-4a8a-b222-11e5b79e1c60
Version: 1
Effective Time: 20200722
 
SOMBRA COSMETICS