OTC Medication Information: Gel Hand Sanitizer with Aloe

GEL HAND SANITIZER WITH ALOE- alcohol gel
SALES AND PRODUCT 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.

Active Ingredient

Ethanol 75%

Purpose

Antiseptic

Uses

To help reduce bacteria on the skin.

Warnings

FLAMMABLE. Keep away from heat or flame

For External Use Only.

When using this product

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately

Do not use

Do not use with children less than 2 months of age

Supervise children under 6 years of age when using this product to avoid swallowing or getting in eyes and on face.

Do not use in open wounds or broken skin.

Stop use and ask a doctor

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

Directions

Apply enough product on hands to cover all surfaces. Rub hands together until dry.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Extract, Acrylates/C10-30 Alkylacrylate Crosspolymer, Triethanolamine, Tocopheryl Acetate, Glycerin, Jojoba Wax PEG-120Esters, Citral, Citronellol, Geraniol, Limonene, Linalool, Fragrance.

Other Information

Store between 59-86F (15-30C). -Avoid freezing and temperatures above 104 F (40C).

Gel Hand Sanitizer with Aloe

label
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label
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GEL HAND SANITIZER WITH ALOE
ethanol 75% gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37520-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 45 mL in 60 mL
Inactive Ingredients
Ingredient Name Strength
CITRAL
GERANIOL
LIMONENE, (+)-
LINALOOL, (+)-
CITRONELLOL ACETATE, (S)-
.ALPHA.-TOCOPHEROL ACETATE
ALOE VERA LEAF
(C10-C30)ALKYL METHACRYLATE ESTER
POTASSIUM HYDROLYZED JOJOBA ESTERS
TROLAMINE
WATER
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37520-101-02 60 mL in 1 BOTTLE None
2 NDC:37520-101-04 120 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/01/2020
Labeler — SALES AND PRODUCT SOLUTIONS (037519852)
Registrant — SALES AND PRODUCT SOLUTIONS (037519852)

Revised: 06/2020 SALES AND PRODUCT SOLUTIONS

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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