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Name:Bullfrog Mosquito Coast
Manufacturer:Chattem, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


BullFrog Mosquito Coast

BULLFROG MOSQUITO COAST - octinoxate, octocrylene, oxybenzone and octisalate spray 
Chattem, 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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BullFrog Mosquito Coast

DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner inconsistent with its labeling. Apply liberally and evenly over dry, exposed skin. Do not spray directly on face. Spray on palm of hand and apply to face. An adult must apply this product to children under 10. For continued protection from mosquitoes, reapply after 8 hours. For sunscreen protection, reapply after toweling off or as needed. Do not exceed 7 applications per day for adults, 3 applications per day for children.

STORAGE:

Store in a cool, dry place. Avoid long term storage above 140ºF (49ºC).

DISPOSAL:

Do Not Puncture or Incinerate!

If empty: Nonrefillable container. Do not reuse or refill this container. Place in trash or offer for recycling if available.

If partly filled: Call your local solid waste agency or 1-800-CLEANUP for disposal instructions.

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS.

CAUTION:

For external use only. Causes moderate eye irritation. Do not get in eyes. Use on children under 6 months of age only with the advice of a physician.

PHYSICAL OR CHEMICAL HAZARDS:

Flammable. Contents under pressure. Keep away from heat, sparks and open flame. Do not puncture or incinerate container. Exposure to temperatures above 130ºF may cause bursting. Avoid contact with plastics.

FIRST AID

If in eyes:

  • Hold eye open and rinse slowly and gently with water for 15-20 minutes.
  • Remove contact lenses, if present, after the first 5 minutes, then continue rinsing the eye.
  • Call a poison control center or doctor for treatment advice.

Have the product container or label with you when calling a poison control center or doctor, or going for treatment. You may also contact 1-800-222-1222 for emergency medical treatment information.

ACTIVE SUNSCREEN INGREDIENTS:

Oxtinoxate (7.5%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%).

INACTIVE INGREDIENTS:

acrylates/octylacrylamide copolymer, SD alcohol 40 (49.08% w/w), aloe barbadensis leaf extract, C12-15 alkyl benzoate, fragrance, isopropyl myristate, isopropyl palmitate, tocopheryl acetate (235-285)

EPA Reg. No.: 40086-1
EPA Est. No.: 40086-TN-001

Not for sale or use after expiration date.

PRINCIPAL DISPLAY PANEL

NEW! DEET FREE
Bull Frog® Mosquito Coast® SPF 30
Repels up to 8 hours
Sunblock with Insect Repellent
Continuous Spray
Suitable for Entire Family
Pleasant Fragrance
UVA/UVB Protection
ACTIVE INGREDIENT:
3-((N-butyl-N-acetyl)amino) propionic acid ethyl ester* 20.0%
OTHER INGREDIENTS: 80.0%
TOTAL: 100.0%
*IR3535® Insect Repellent U.S. Patent No. 7,037,515
KEEP OUT OF REACH OF CHILDREN
CAUTION
NET CONTENTS 6 FL OZ (177 mL)

PRINCIPAL DISPLAY PANEL NEW! DEET FREE Bull Frog® Mosquito Coast® SPF 30 KEEP OUT OF REACH OF CHILDREN NET CONTENTS 6 FL OZ (177 mL)

BULLFROG MOSQUITO COAST 
octinoxate and octisalate and octocrylene and oxybenzone spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-3307
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.075 g  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.1 g  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 0.06 g  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 0.05 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF  
ALKYL (C12-15) BENZOATE  
ISOPROPYL MYRISTATE  
ISOPROPYL PALMITATE  
.ALPHA.-TOCOPHEROL ACETATE, D-  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-3307-3 177 mL in 1 CAN None
2 NDC:41167-3307-7 139 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 11/01/2005

Labeler - Chattem, Inc. (003336013)
Establishment
Name Address ID/FEI Operations
Chattem Plant 1 003336013 MANUFACTURE, PACK

Revised: 05/2011 Chattem, Inc.



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


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