Luxury Hand Sanitizer Aloe: Package Insert and Label Information

LUXURY HAND SANITIZER ALOE- alcohol gel
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI

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.

Active Ingredients

Ethyl Alcohol 70%

Purpose: Antiseptic

Purpose

Antiseptic

Uses

  • helps reduce bacteria on the skin
  • For use when soap and water are not available

Directions

  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Safety Instructions

Flammable, Keep away from fire and flame

Ask Doctor

Stop Use and Ask a doctor if irritation or redness develops

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, get medical help or contact Poison Control Center immediately.

Other Information

Store below 110°F (43°C)
May discolor certain fabrics or surfaces.

Inactive Ingredients

water, glycerin, carbomer, aminomethyl propanol, fragrance, Aloe, Tocopheryl Acetate. Please review Label for further details

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LUXURY HAND SANITIZER ALOE
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76772-021
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALOE VERA LEAF
GLYCERIN
CARBOMER COPOLYMER TYPE A
.ALPHA.-TOCOPHEROL ACETATE, D-
AMINOMETHYLPROPANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76772-021-47 472 mL in 1 BOTTLE None
2 NDC:76772-021-06 60 mL in 1 BOTTLE None
3 NDC:76772-021-23 236 mL in 1 BOTTLE None
4 NDC:76772-021-10 1000 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 10/01/2020
Labeler — TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
Registrant — TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
Establishment
Name Address ID/FEI Operations
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI 533120570 manufacture (76772-021)

Revised: 10/2020 TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI

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