Obsess Hand Sanitizer - Unscented

Obsess Hand Sanitizer - Unscented by

Drug Labeling and Warnings

Obsess Hand Sanitizer - Unscented by is a Otc medication manufactured, distributed, or labeled by Black Diamond Coatings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OBSESS HAND SANITIZER - UNSCENTED- isopropyl alcohol liquid 
Black Diamond Coatings, 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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Obsess Hand Sanitizer - Unscented

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. Isopropyl Alcohol (76%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Aloe Vera (1.45% v/v).
  3. Hydrogen peroxide (0.29% v/v).
  4. Sterile distilled water.

Active Ingredient(s)

Isopropyl Alcohol 76% 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

  • in children less than 2 months of age
  • on open skin wounds

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

purified water USP, aloe barbadensis extract, hydroxypropyl guar gum, hydrogen peroxide

Package Label - Principal Display Panel

118 ml NDC: 80831-001-00 4 oz Label - Bottle

OBSESS HAND SANITIZER - UNSCENTED 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80831-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL76 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.29 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 22 mL  in 100 mL
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC) 0.4 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80831-001-00118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
2NDC: 80831-001-0180 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
3NDC: 80831-001-03946 mL in 1 BOTTLE; Type 0: Not a Combination Product10/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/12/202011/01/2021
Labeler - Black Diamond Coatings, Inc. (079363329)
Registrant - Black Diamond Coatings, Inc. (079363329)
Establishment
NameAddressID/FEIBusiness Operations
Black Diamond Coatings079363329manufacture(80831-001)

Revised: 1/2022
Document Id: d5de5e9c-b36b-dbf3-e053-2995a90a78d0
Set id: b114b20b-65c4-1868-e053-2a95a90a5608
Version: 2
Effective Time: 20220118