ORIGINAL HAND SANITIZER GEL FIG RHUBARB- isopropyl alcohol 70% v/v gel 
Pame Eco Technology Inc

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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Original Hand Sanitizer Fig Rhubarb 70% IPA gel

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Water, Glycerin, Castor Seed Oil, Isopropyl Myristate, Acrylates Copolymer, Aloe Vera Juice, Tocopheryl Acetate, Triethanolamine, Fragrance.

Package Label - Principal Display Panel

500 mL NDC: 81451-143-05

Label

ORIGINAL HAND SANITIZER GEL FIG RHUBARB 
isopropyl alcohol 70% v/v gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81451-143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CASTOR OIL (UNII: D5340Y2I9G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81451-143-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/25/2021
Labeler - Pame Eco Technology Inc (204258441)
Registrant - Pame Eco Technology Inc (204258441)
Establishment
NameAddressID/FEIBusiness Operations
Pame Eco Technology Inc204258441manufacture(81451-143)

Revised: 8/2021
Document Id: ca6c5191-d969-e83e-e053-2995a90a13f3
Set id: ca6c50ca-1a57-b89e-e053-2995a90ae7d6
Version: 1
Effective Time: 20210825
 
Pame Eco Technology Inc