CHAFEZONE- skin protectant stick

ChafeZone by

Drug Labeling and Warnings

ChafeZone by is a Otc medication manufactured, distributed, or labeled by Medzone Products LLC, Dhaliwal Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS Active Ingredient

• Active Ingredient: Purpose
• Dimethicone 1%: Skin Protectant

Purpose

Skin Protectant

Uses:

Temporarily protects and helps relieve chapped or cracked skin. Helps protect from the drying 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 children.

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 Barbadensis Leaf Juice, Beeswax, Benzoic Acid, BHT, Bisabolol, Butylene/ethylene/styrene Copolymer, Caprylic Capric Triglyceride, C18-36 Acid Triglyceride, ethylene/propylene/styrene copolymer, ethylhexylglycerin, eucalyptus oil, ginkgo biloba leaf extract, glycereth-2 cocoate, glycerin, tea tree leaf oil, peppermint oil, Menthyl lactate, mineral oil, petrolatum, phenoxyethanol, tocopheryl acetate, tribehenin.

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

principal display

INGREDIENTS AND APPEARANCE

CHAFEZONE 
skin protectant stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70338-631
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
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE (UNII: AUG1H506LY)
STYRENE (UNII: 44LJ2U959V)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
YELLOW WAX (UNII: 2ZA36H0S2V)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
1-BUTENE (UNII: LY001N554L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70338-631-70	43 g in 1 APPLICATOR; Type 0: Not a Combination Product	07/01/2016
2	NDC: 70338-631-00	23 g in 1 PACKET; 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)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Laboratories LLC		016754201	manufacture(70338-631)