ASTRINGENT- aluminum acetate gel 
CA-BOTANA INTERNATIONAL

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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Hydrogel Formulated with COSMEDERM7 For temporary Relief of Minor Itching and Burning

For external use only. Avoid contact with eyes. Keep out of reach of children. Do not apply to open wounds. STOP USE AND ask a doctor if condition worsens or symptoms persist for more than seven days, discontinue use of the product.

Adults and children two years of age and older, apply to affected area not more than three times daily or as directed by a doctor. Consult a physician for children under the age of two.

Butylene Glycol,
Caprylyl Glycol,
Dehydroacetic Acid,
Ethylhexylglycerin,
Glycine,
Hexylene Glycol,
Malic Acid,
Phenoxyethanol,
Purified Water,
Strontium Chloride Hexahydrate,
Xanthan Gum.

Astringent

  1. Aluminium acetate

For external use only.
Avoid contact with eyes.
Keep out of reach of children.
Do not apply to open wounds.
STOP USE AND ask a doctor if condition worsens or
symptoms persist for more than seven days, discontinue
use of the product.

  1. Adults and children two years of age and older, apply to affected area not more than three times daily or as directed by a doctor. Consult a physician for children under the age of two.

image of label

ASTRINGENT 
aluminum acetate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ACETATE0.008 mg  in 4 mL
Inactive Ingredients
Ingredient NameStrength
Butylene Glycol (UNII: 3XUS85K0RA)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Dehydroacetic Acid (UNII: 2KAG279R6R)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Glycine (UNII: TE7660XO1C)  
Hexylene Glycol (UNII: KEH0A3F75J)  
Malic Acid (UNII: 817L1N4CKP)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Water (UNII: 059QF0KO0R)  
Strontium Chloride Hexahydrate (UNII: O09USB7Z44)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-005-044 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2015
Labeler - CA-BOTANA INTERNATIONAL (106276728)
Registrant - RODOLFO UGELSTAD (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-BOTANA INTERNATIONAL106276728manufacture(35192-005)

Revised: 1/2015
Document Id: 6e2ff42f-edbc-4526-9f86-33cdb8c93d1e
Set id: 912cbb41-de59-4062-9252-42b0a84f3aac
Version: 1
Effective Time: 20150101
 
CA-BOTANA INTERNATIONAL