Label: CHAFEZONE- skin protectant stick
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Contains inactivated NDC Code(s)
NDC Code(s): 70338-631-00, 70338-631-70 - Packager: Medzone Products LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 31, 2021
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- DRUG FACTS Active Ingredient
- Purpose
- Uses:
- Warnings
- Directions:
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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.
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INGREDIENTS AND APPEARANCE
CHAFEZONE
skin protectant stickProduct 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)