OTC Medication Information: NamaHandSanitizer

NAMAHANDSANITIZER- alcohol solution
Cospro Development Corp.

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.

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) (70%)
  2. Glycerol
  3. distilled water

Active Ingredient(s)

Alcohol 70%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from fire and flame

Do not use

do not use in or near eyes

When using this product do not use in or near eyes. If contact occurs, 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

  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

Other information

  • Store below 110F (43C)

Inactive ingredients

glycerin, polysorbate 20, aloe barbadensis leaf juice, tocopheryl acetate, maltodextrin, purified water

Package Label — Principal Display Panel

image description
(click image for full-size original)

NAMAHANDSANITIZER
alcohol solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46607-117
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
POLYSORBATE 20
WATER
ALOE
MALTODEXTRIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46607-117-01 242 mL in 1 BOTTLE None
2 NDC:46607-117-02 59 mL in 1 BOTTLE None
3 NDC:46607-117-03 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/29/2020
Labeler — Cospro Development Corp. (785638821)
Registrant — Cospro Development Corp. (785638821)
Establishment
Name Address ID/FEI Operations
Cospro Development Corp. 785638821 manufacture (46607-117), pack (46607-117), label (46607-117)

Revised: 06/2020 Cospro Development Corp.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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