SKIN PROTECTANT- astrigent cream 
CA-Botana International

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Skin Protectant Dermaleve: Advanced Formula Soothing Cream

Aluminum acetate 0.2%

For external use only. Avoid contact with eyes. Do not apply to open wounds. S TOP USE and ask a doctor if condition worsens or symtomps persist for more than seven days. Keep out reach of children

Directions: Adults and childrens tho years of age and older apply to affected area as needed or as directed by a doctor. Consult a doctor for children under the age of two

Relieves minor skin irritations due to poison Ivi. Poison oak. Poison sumac. Insect bites Athlete's foot. Allergic itches. Irritations

Cetyl Alcohol, Dimethico 100, Polyacrylic Acid, Polawax Polysorbate, Glycerin, Caprylyl Glycol, Ceramide NG, Water, Magnesium Aluminum Silicate, Glyceryl Stearate, Edenate Disodium, Tocopherol, Tetrahexyldecyl Ascorbate, Shea Butter, Phenoxyethanol, Strontium Nitrate, Xanthan Gum Hyaloronic acid, Stearyl Alcohol, IsopropyylMyrristate, Caprylic/Capric Tryglyceride

use 3 times to[pically

Keep out of reach of children

For external use only Avoid contact with eyes Do not apply to open wound Stop use and ask a doctor if condition worsens or symtomps persist for more than seven days Keep out reach of children

dermaleve_sample_with_Crimp (1).jpg

SKIN PROTECTANT 
astrigent cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-041
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ACETATE0.2 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
XANTHAN GUM (UNII: TTV12P4NEE)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE NG (UNII: C04977SRJ5)  
WATER O-18 (UNII: 7QV8F8BYNJ)  
MAGNESIUM ALUMINUM SILICATE TYPE IA (UNII: SUS08ZOA9S)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STRONTIUM NITRATE (UNII: BDG873AQZL)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE 100 (UNII: RO266O364U)  
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
HYALURONIC ACID (UNII: S270N0TRQY)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-041-153 g in 1 POUCH; Type 0: Not a Combination Product10/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01610/27/2020
Labeler - CA-Botana International (106276728)
Registrant - Rodolfo Ugelstad (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-Botana International106276728manufacture(35192-041)

Revised: 10/2023
Document Id: 080f7d09-f0c3-20e0-e063-6294a90ad273
Set id: b2342951-0f79-a4cb-e053-2a95a90aa4fc
Version: 5
Effective Time: 20231019
 
CA-Botana International