ECZEMA FAST HEALING by Genuine Virgin Aloe Corporation / MCKENNA LABS, INC. Eczema Fast Healing

ECZEMA FAST HEALING by

Drug Labeling and Warnings

ECZEMA FAST HEALING by is a Otc medication manufactured, distributed, or labeled by Genuine Virgin Aloe Corporation, MCKENNA LABS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECZEMA FAST HEALING- oatmeal lotion 
Genuine Virgin Aloe Corporation

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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Eczema Fast Healing

ACTIVE INGREDIENT

COLLOIDAL OATMEAL 1.5%

PURPOSE

SKIN PROTECTANT

USES

TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATION AND ITCHING DUE TO:

• ECZEMA
• RASHES
  

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

• ON DEEP PUNCTURE WOUNDS
• ON INFECTIONS
• ON LACERATIONS
  

WHEN USING THIS PRODUCT

• DO NOT GET INTO EYES

STOP USE AND ASK A DOCTOR IF

• CONDITION WORSENS
• SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS.
  

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS:

• APPLY TWICE A DAY OR AS NEEDED.
  

Inactive ingredients: aleurites moluccana seed (kukui nut) oil,allantoin, aloe barbadensis (AP4® genuine virgin organic aloe vera) leaf extract, arnica (montana flower) extract, beeswax, butyrospermum parkii (shea butter), caprylic capric triglyceride, cetearyl alcohol, cetyl alcohol, dimethicone, disodium EDTA, glycerin, panthenol (pro vitamin B5), petrolatum, phenoxyethanol, polysorbate 60, retinyl palmitate (vitamin A), sodium hyaluronate, sodium PCA, squalane, tocopheryl acetate (vitamin E), triethanolamine, urea, zinc PCA

ECZEMA FAST HEALING 
oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
KUKUI NUT OIL (UNII: TP11QR7B8R)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
UREA (UNII: 8W8T17847W)
ZINC PIDOLATE (UNII: C32PQ86DH4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10738-102-54	1 in 1 BOX	01/03/2014	08/01/2019
1	NDC: 10738-102-14	119 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/03/2014	08/01/2019

Labeler - Genuine Virgin Aloe Corporation (961374147)

Registrant - Genuine Virgin Aloe Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
MCKENNA LABS, INC.		090631412	manufacture(10738-102)

Revised: 1/2020

Document Id: 06c1ca7e-22dc-49be-97e4-1ed51391a345

34390-5

Set id: 5354f623-9189-4e37-a232-5559f9e8d00f

Version: 3

Effective Time: 20200113

 

Genuine Virgin Aloe Corporation