Ultimate Solutions Hand Sanitizer

Ultimate Solutions Hand Sanitizer by

Drug Labeling and Warnings

Ultimate Solutions Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ultimate Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTIMATE SOLUTIONS HAND SANITIZER- alcohol gel 
Ultimate Solutions

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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Ultimate Solutions Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

• To decrease bacteria on the skin that potentially can cause disease.
• Recommended for repeated use.

Warnings

• Flammable, keep away from heat or flame.
• For external use only.

Keep out of eyes, ears or mouth. In case of eye contact, flush with water.

Stop use and ask a doctor if irritation and redness develop or if 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. Children should be supervised by an adult when using this product.

Directions

• Apply sufficient amount of product to your palm to cover both hands.
• Rub until dry.

Other Information

May discolor certain fabrics and surfaces.

Inactive ingredients

Acrylates/C 10/30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, D&C Blue 1, FD&C Yellow 5, Fragrance, PEG/PPG-18/18 Dimethicone, Purified Water, Triethanolamine, Vitamin E

Ultimate Soluitions. Inc.

Englewood, NJ 07631

ULTIMATE SOLUTIONS HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81571-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TROLAMINE (UNII: 9O3K93S3TK)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81571-001-27	800 mL in 1 POUCH; Type 0: Not a Combination Product	02/18/2021	10/12/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/18/2021	10/12/2022

Labeler - Ultimate Solutions (607993826)

Revised: 1/2023

Document Id: f279a6f3-96c8-48ea-e053-2995a90a5eb5

34390-5

Set id: bb9f62b1-b6c4-e8c9-e053-2a95a90a94ca

Version: 2

Effective Time: 20230102