LATHER- HAND SANITIZER WITH MOISTURIZING ALOE  70 PERCENT- ethyl alcohol gel 
Lather, Inc.

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 WITH MOISTURIZING ALOE (70% ETHYL ALCOHOL) (77394-101) - DELIST

ACTIVE INGREDIENT

ETHYL ALCOHOL 70%

PURPOSE

ANTIMICROBIAL

USES

TO DECREASE BACTERIA AND VIRUSES ON THE SKIN THAT COULD CAUSE DISEASE - RECOMMENDED FOR REPEATED USE, WHEN HAND WASHING IS NOT AVAILABLE.

WARNINGS

For external use only: hands.

Flammable, keep away from fire or flame.

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 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 105°F
  • may discolor some fabrics
  • harmful to wood finishes and plastics

INACTIVE INGREDIENTS:

Water, Glycerin, Isopropyl Alcohol, Citrus Aurantium Dulcis (Orange) Oil, Propanediol, Rosa Damascena Flower Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Aloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Leaf Extract, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol


01b LBL_lather-handsanitizer-HS-1gal

LATHER- HAND SANITIZER WITH MOISTURIZING ALOE   70 PERCENT
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77394-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ORANGE OIL (UNII: AKN3KSD11B)  
PROPANEDIOL (UNII: 5965N8W85T)  
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
WITCH HAZEL (UNII: 101I4J0U34)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77394-101-113780 mL in 1 JUG; Type 0: Not a Combination Product05/08/202012/31/2022
2NDC:77394-101-12295 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/08/202012/31/2022
Labeler - Lather, Inc. (100666606)

Revised: 10/2023
Document Id: 06d48cc9-3ef8-f0ea-e063-6294a90af3e5
Set id: 0054a449-95ca-419c-8f4d-4c7d681d2b72
Version: 9
Effective Time: 20231003
 
Lather, Inc.