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Hand Sanitizer with NDC 00000-000 is a a human over the counter drug product labeled by NTML Group Ltd. The generic name of Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.
Hand Sanitizer
FDA Label NDC 77366-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ntml Group Ltd for the product Hand Sanitizer (NDC 77366-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
For handwashing to decrease bacteria on the skin
Recommended for repeated use
Warnings
For external use only
Flammable, keep away from fire and flame
Do not drink
If taken internally will produce serious gastric disturbances
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product avoid the eyes and mucous membrane
In the case of eyes or mucous membranes contact, rinse area thoroughly with water
Otc - Stop Use
Stop use and ask a doctor if condition worsens, redness or irritation develops
If condition persists for more than 3 days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed contact a doctor or Poison Control Center immediately.
Directions
Rub dime sized amount between hands until dry
Supervise children in the use of this product
In the case of eye contact, rinse eyes thoroughly with water
Other Information
Store below 105 F
May discolour some fabrics
Inactive Ingredients
Aminomethyl Propanol, Carbomer, Glycerin, Propylene Glycol, Water.
Package Label - Principal Display Panel
70% Alcohol Gel
1000 mL (3.38 fl oz)
100 mL Label (Sundays Text V2)
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