PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER- alcohol gel 
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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PURE & ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER

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

image description

PURE ESSENTIAL MINERALS ANTIBACTERIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-1118
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)  
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-1118-8237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/16/2020
2NDC:61577-1118-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/16/2020
3NDC:61577-1118-6474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/16/2020
Labeler - SOMBRA COSMETICS (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS097464309manufacture(61577-1118) , label(61577-1118)

Revised: 7/2020
Document Id: 6a955818-0497-47b8-af66-4f56b9608a68
Set id: b322f9a2-7bdd-4acd-a3e0-527cc07ba6bb
Version: 2
Effective Time: 20200716
 
SOMBRA COSMETICS