BLISTERZONE- skin protectant stick

BlisterZone by

Drug Labeling and Warnings

BlisterZone by is a Otc medication manufactured, distributed, or labeled by MedZone Products LLC, Richard Hamer Associates LLC, Biomed Laboratories LLC, MicroConsult Inc, Ceutical Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

For 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

HOW SUPPLIED

Distributed by MedZone Products LLC

Lenexa, Kansas 66215

All rights reserved

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BLISTERZONE 
skin protectant stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70338-611
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70338-611-00	23 g in 1 APPLICATOR; Type 0: Not a Combination Product	07/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/01/2016

Labeler - MedZone Products LLC (080083739)

Registrant - Richard Hamer Associates LLC (067731889)

Establishment
Name	Address	ID/FEI	Business Operations
Biomed Laboratories LLC		055329696	manufacture(70338-611) , pack(70338-611)

Establishment
Name	Address	ID/FEI	Business Operations
MicroConsult Inc		062183608	analysis(70338-611)

Establishment
Name	Address	ID/FEI	Business Operations
Ceutical Laboratories Inc		789485153	analysis(70338-611)