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Name:Noevir Raysela
Manufacturer:Noevir Usa Inc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NOEVIR RAYSELA  - zinc oxide, octinoxate and titanium dioxide cream 
NOEVIR USA INC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Drug Facts

Drug Facts
Active Ingredients                       Purpose
ZINC OXIDE  14.25%                  Sunscreen
OCTINOXATE  7.5%                   Sunscreen
TITANIUM DIOXIDE 2.07%         Sunscreen

Uses
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Provides high protection against sunburn.
Warnings
For external use only.
When using this product
  • Keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if
  • Rash or irritation develops and lasts.
Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away.
Directions
  • Apply evenly before sun exposure.
  • Children under 6 months of age ask a doctor.
  • Reapply as needed or after towel drying, swimming or sweating.
Other Information
Sun Alert
Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

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NOEVIR RAYSELA 
zinc oxide, octinoxate, titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62908-011
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 14250 mg  in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 7500 mg  in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2070 mg  in 100 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62908-011-02 1 TUBE ( TUBE) in 1 BOX contains a TUBE (62908-011-01)
1 NDC:62908-011-01 35 g in 1 TUBE This package is contained within the BOX (62908-011-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2010

Labeler - NOEVIR USA INC (018593293)
Registrant - NOEVIR USA INC (018593293)
Establishment
Name Address ID/FEI Operations
NOEVIR USA INC 018593293 manufacture

Revised: 11/2009 NOEVIR USA INC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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