ALOESAFE ANTISEPTIC HAND SANITIZER- ethyl alcohol liquid 
Medical Chemical Corporation

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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AloeSafe

Indications for Use

Indications for use: AloeSafe is intended to be used as a waterless hand sanitizer to reduce microorganisms that can cause disease. Recommended fo repeated use.

Ingredients

Ingredients: Ethyl alcohol 62% (active ingredient), purified water, carbomer, aloe vera gel, diisopropylamine, vitamin E, and lavender oil.

Ingredients

Ingredients: Ethyl alcohol 62% (active ingredient), purified water, carbomer, aloe vera gel, diisopropylamine, vitamin E, and lavender oil.

Warnings

Warnings: Flammable, keep away from fire or flames. For external use on hands only. Avoid contact with face, eyes and broken skin. If this occurs, flush thoroughly with water. Discontinue use if irritation or redness develops. Keep out of reach of children. In case of ingestion contact Poison Control Center immediately.

Warnings

Warnings: Flammable, keep away from fire or flames. For external use on hands only. Avoid contact with face, eyes and broken skin. If this occurs, flush thoroughly with water. Discontinue use if irritation or redness develops. Keep out of reach of children. In case of ingestion contact Poison Control Center immediately.

Warnings

Warnings: Flammable, keep away from fire or flames. For external use on hands only. Avoid contact with face, eyes and broken skin. If this occurs, flush thoroughly with water. Discontinue use if irritation or redness develops. Keep out of reach of children. In case of ingestion contact Poison Control Center immediately.

Directions

Directions: Wet hands thoroughly with AloeSafe and rub briskly until dry without wiping.

Indications for use

Indications for use: AloeSafe is intended to be used as a waterless hand sanitizer to reduce microorganisms that can cause disease. Recommended fo repeated use.

AloeSafe Label

AloeSafe Label

ALOESAFE  ANTISEPTIC HAND SANITIZER
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12745-180
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3) 0.25 g  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.2 g  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.02 g  in 100 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.04 g  in 100 mL
WATER (UNII: 059QF0KO0R) 28.03 g  in 100 mL
DIISOPROPYLAMINE (UNII: BR9JLI40NO) 0.2 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12745-180-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/14/2019
2NDC:12745-180-02120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2010
3NDC:12745-180-03480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/01/2010
Labeler - Medical Chemical Corporation (008496861)
Registrant - Medical Chemical Corporation (008496861)
Establishment
NameAddressID/FEIBusiness Operations
Medical Chemical Corporation008496861manufacture(12745-180)

Revised: 1/2022
Document Id: d5d0b340-3351-b4f9-e053-2995a90a0cbd
Set id: 950f012e-7908-523c-e053-2995a90afa6b
Version: 3
Effective Time: 20220117
 
Medical Chemical Corporation