BLISTERZONE- skin protectant stick 
MedZone Products LLC

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.

----------

Active Ingredient

Dimethicone 1%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin. Helps protect from the druing effects of wind and cold weather,

Warnings

Back PanelFor external use only.

When using this product

  • do not get into eyes.

Stop use and ask a physician if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on:

  • deep or puncture wounds
  • serious burns
  • animal bites

Keep out of reach of chlidren

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally as needed before athletic activity or to areas of repetitive friction/rubbing

Inactive Ingredients

Aloe Vera Leaf, Alpha-Tocopheryl Acetate, 1-Butene, C18-36 Acid Triglyceride, Ethylene, Eucalyptus Oil, Ginkgo, Levomenol, Medium-Chain Triglycerides, Menthyl Lactate, Methylparaben, Mineral oil, Peppermint Oil, Petrolatum, Propylene, Propylparaben, Styrene, Tea Tree Oil, Tribehenin, Yellow Wax

Other Information

Store at room temperature. Avoid excessive heat.

Questions?

Toll-Free 866-MEDZONE (866-633-9663)

www.medzonecorp.com info@medzonecorp.com

Distributed by MedZone Products LLC

Lenexa, Kansas 66215

All rights reserved

BlitserzonePDP

BLISTERZONE 
skin protectant stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-611
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
STYRENE (UNII: 44LJ2U959V)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
1-BUTENE (UNII: LY001N554L)  
ETHYLENE (UNII: 91GW059KN7)  
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GINKGO (UNII: 19FUJ2C58T)  
LEVOMENOL (UNII: 24WE03BX2T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE (UNII: AUG1H506LY)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70338-611-0023 g in 1 APPLICATOR; Type 0: Not a Combination Product07/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/2016
Labeler - MedZone Products LLC (080083739)
Registrant - Richard Hamer Associates LLC (067731889)
Establishment
NameAddressID/FEIBusiness Operations
Biomed Laboratories LLC055329696manufacture(70338-611) , pack(70338-611)
Establishment
NameAddressID/FEIBusiness Operations
MicroConsult Inc062183608analysis(70338-611)
Establishment
NameAddressID/FEIBusiness Operations
Ceutical Laboratories Inc789485153analysis(70338-611)

Revised: 2/2018
Document Id: 650889c6-2c80-7368-e053-2991aa0a7720
Set id: 3760752a-1d84-5d45-e054-00144ff88e88
Version: 2
Effective Time: 20180212
 
MedZone Products LLC