PERFORMANCE PLUS- hand sanitizer gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

Diamond Chemical Co Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose………………………….…. Antimicrobial - Hand sanitize to help decrease bacteria on the skin. Stop use and ask a doctor if irritation or rash appears and lasts. Stop use and ask a doctor if irritation or rash appears and lasts.

Authorization status:

OTC monograph not final

Summary of Product characteristics

PERFORMANCE PLUS- HAND SANITIZER GEL
DIAMOND CHEMICAL CO 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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PERFORMANCE PLUS GEL HAND SANITIZER
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:
a. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured
according to Alcohol
and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
b. Glycerol (1.45% v/v).
c. Hydrogen peroxide (0.125% v/v).
d. 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
Active Ingredient…... Ethyl alcohol 70% v/v
PURPOSE
Purpose………………………….…. Antimicrobial
USE
Hand sanitize to help decrease bacteria on the skin.
WARNINGS
FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.
FOR EXTERNAL USE ONLY.
DO NOT USE
STOP USE AND ASK A DOCTOR IF irritation or rash appears and lasts.
WHEN USING THIS PRODUCT do not use in or near the eyes. In case of
contact, rinse eye
thoroughly with water.
STOP USE AND ASK A DOCTOR IF irritation or rash appears and lasts.
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
If hands are visibly soiled, wash with soap and water then dry hands.
Wet hands thoroughly with product, especially under the fingernails
and allow to dry
without rinsing.
Children under 6 years of age should be supervised when usin