LATHER 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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Lather Hand Sanitizer

Active Ingredients

Ethyl Alcohol 65%

Uses

To decrease bacteria and viruses on the skin that could cause disease.  Recommended for repeated use, when hand washing is not available.

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

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 if irritation and redness develop. Condition persists more than 72  hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.  For children under 6, use only under adult supervision.  Not recommended for infants.

Directions

Wet hands thoroughly and allow to dry without wiping.

Other information

Do not store above 105F.  May discolor some fabrics.  Harmful to wood finishes and plastics.

Inactive ingredients

glycerin, purified water, isopropyl alcohol, polyacrylate crosspolymer-6, rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, aloe barbadensis leaf juice, citrus aurantium dulcis (orange) peel oil, yucca schidigera stem extract, filipendula rubra extract, camellia sinensis (green tea) leaf extract.

Purpose

Antiseptic

Los Poblanos 8oz gel

LATHER HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-1114
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
ORANGE PEEL (UNII: TI9T76XD44)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
WITCH HAZEL (UNII: 101I4J0U34)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
FILIPENDULA RUBRA WHOLE (UNII: MT26BL24AZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-1114-4236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/15/2020
2NDC:61577-1114-3296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/15/2020
3NDC:61577-1114-6473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/15/2020
4NDC:61577-1114-259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/2020
Labeler - SOMBRA COSMETICS (097464309)
Establishment
NameAddressID/FEIBusiness Operations
SOMBRA COSMETICS097464309manufacture(61577-1114)

Revised: 7/2020
Document Id: fb046a9c-a143-47b3-92bc-c1e85f27f115
Set id: e15b7e47-739a-45aa-a834-d1268a30b08b
Version: 1
Effective Time: 20200715
 
SOMBRA COSMETICS