SKIN PROTECTANT- astrigent cream

Skin protectant by

Drug Labeling and Warnings

Skin protectant by is a Otc medication manufactured, distributed, or labeled by CA-Botana International, Rodolfo Ugelstad, CA-Botana International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

use 3 times to[pically

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN PROTECTANT 
astrigent cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM ACETATE	0.2 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
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 TRIGLYCERIDE (UNII: C9H2L21V7U)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-041-15	3 g in 1 POUCH; Type 0: Not a Combination Product	10/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/27/2020

Labeler - CA-Botana International (106276728)

Registrant - Rodolfo Ugelstad (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-Botana International		106276728	manufacture(35192-041)