2 IN 1 HAND SANITIZER/DISINFECTANT- isopropyl alcohol liquid 
Rocky Research

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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2 in1 Hand Sanitizer/Disinfectant

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

  1. Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.5% v/v).
  3. Hydrogen peroxide (0.126% v/v).
  4. Distilled water.
  5. Aloe.
  6. Essential oil.

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer & Surface Disinfectant

Use

Hand Sanitize and surface disinfectantr 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

glycerin, hydrogen peroxide, distilled water, aloe, essential oil

Package Label - Principal Display Panel

2in1 473ml label473 ml NDC: 77509-070-01

2 IN 1 HAND SANITIZER/DISINFECTANT 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77509-070
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.126 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77509-070-01473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/25/2020
Labeler - Rocky Research (152672127)
Registrant - Rocky Research (152672127)
Establishment
NameAddressID/FEIBusiness Operations
Rocky Research152672127manufacture(77509-070)

Revised: 5/2020
Document Id: a6b8617b-7401-5287-e053-2995a90aabfa
Set id: a58fe22b-45c8-3032-e053-2995a90a6f4a
Version: 2
Effective Time: 20200528
 
Rocky Research