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NDC 70338-0611-00 BlisterZone 10 mg/g Details

BlisterZone 10 mg/g

BlisterZone is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by MedZone Products LLC. The primary component is DIMETHICONE.

Product Information

NDC	70338-0611
Product ID	70338-611_650889c6-2c80-7368-e053-2991aa0a7720
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BlisterZone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Skin Protectant
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
Substance Name	DIMETHICONE
Labeler Name	MedZone Products LLC
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70338-0611-00 (70338061100)

Pricing Information	N/A
NDC Package Code	70338-611-00
Billing NDC	70338061100
Package	23 g in 1 APPLICATOR (70338-611-00)
Marketing Start Date	2016-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3760752a-1d84-5d45-e054-00144ff88e88 Details

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 [email protected]

SPL UNCLASSIFIED SECTION

Distributed by MedZone Products LLC

Lenexa, Kansas 66215

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70338-611-00	23 g in 1 APPLICATOR; Type 0: Not a Combination Product	07/01/2016

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

Labeler - MedZone Products LLC (080083739)

Registrant - Richard Hamer Associates LLC (067731889)

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

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

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

Revised: 2/2018

Document Id: 650889c6-2c80-7368-e053-2991aa0a7720

Set id: 3760752a-1d84-5d45-e054-00144ff88e88

Version: 2

Effective Time: 20180212