Drug Labeling and Warnings

Drug Details

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ADVANCE HAND SANITIZER MOISTURIZING FORMULA WITH ALOE AND VITAMIN E- alcohol gel 
All Pharma LLC

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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Active ingredient

Isopropyl Alcohol 70.0%

Purpose

Antimicrobial

Uses

To help decrease bacteria on the skin. Recommended for repeat use.

Warnings

For external use only.

Flammable. Keep away from heat and flame.

When using this product

Keep out of eyes. In case of contact, rinse eyes thoroughly with water

Avoid contact with broken skin

Do not inhale or ingest

Stop use and ask a doctor if

If irritation or redness develops.

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

Inactive ingredients

aloe barbadensis powder, amino-methyl-propanol, carbomer, glycerin,
isopropyl myristate, propylene glycol, tocopheryl acetate, water

label

ADVANCE HAND SANITIZER MOISTURIZING FORMULA WITH ALOE AND VITAMIN E 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53149-1100
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)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53149-1100-3946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
2NDC: 53149-1100-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
3NDC: 53149-1100-2354 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
4NDC: 53149-1100-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
5NDC: 53149-1100-8236 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/2020
Labeler - All Pharma LLC (078572520)
Registrant - All Pharma LLC (078572520)
Establishment
NameAddressID/FEIBusiness Operations
All Pharma LLC078572520manufacture(53149-1100)

Revised: 4/2019
 
All Pharma LLC


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