CHAFEZONE- 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.

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ChafeZone



DRUG FACTS



Active Ingredient

Active IngredientPurpose
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

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CHAFEZONE 
skin protectant stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70338-631
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70338-631-7043 g in 1 APPLICATOR; Type 0: Not a Combination Product07/01/2016
2NDC:70338-631-0023 g in 1 PACKET; 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)
Establishment
NameAddressID/FEIBusiness Operations
Dhaliwal Laboratories LLC016754201manufacture(70338-631)

Revised: 12/2021
Document Id: d477f37d-3d06-39c8-e053-2995a90ab7dd
Set id: 26a2ba34-eb41-614d-e054-00144ff88e88
Version: 6
Effective Time: 20211231
 
Medzone Products LLC