Theruptor
FDA Label NDC 80192-208
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Carenow Medical Pvt Ltd for the product Theruptor (NDC 80192-208). 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 drug facts, active ingredient:, purpose, uses:, warnings:, otc - stop use, otc - keep out of reach of children, direction of use:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient:
Ethanol denatured equivalent to Ethanol 70% v/v
Purpose
Antiseptic
Uses:
- Indicated for rapid hand disinfection and sanitization.
- Recommended for repeated use.
Warnings:
For external Use only
Flammable. Keep away from heat or flame.
Do not use: In children less than 2 months of age or on open skin wounds. Supervise children under 6 years of age when using this product.
Otc - Stop Use
Stop use and ask doctor if irritation or rash occurs, conditions persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of children, If swallowed, get medical help or contact a Poison Control Center right away.
Direction Of Use:
- Open the canister cap and pull a wipe
- Keep package tightly closed.
- Wet hands thoroughly with product and allow to dry.
- Residual alcohol should be emptied prior to disposing.
- Dispose wipes and package in accordance with local regulation
- Once opened, keep canister tightly closed.
Inactive Ingredient:
Glycerine, Fragrance and purified water.
Size of Wipe : 15 x 20cm
Other Information:
- Store below 110°F (43°C)
Proven Anti-microbial Efficacy - provides rapid bactericidal action against a broad spectrum of micro organisms.
Skin Antiseptic formula with a combination of alcohol and skin emollients for effective bactericidal, fungicidal & Viricidal activity.
Moisturized with skin emollients to prevent skin dryness and damage.
Package Label - Principal Display Panel
NDC 80192-208-01
THERUPTOR® Wipes-70EA - 70 wipes
Ndc 80192-208-01 (Theruptor 70 Wipes)
NDC 80192-204-02
THERUPTOR® Wipes-70EA - 50 wipes
Ndc 80192-204-02 (Theruptor 50 Wipes)
* Please review the disclaimer below.
