ASTRINGENT- aluminum acetate gel

Astringent by

Drug Labeling and Warnings

Astringent by is a Otc medication manufactured, distributed, or labeled by CA-BOTANA INTERNATIONAL, RODOLFO UGELSTAD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

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.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

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

PURPOSE

Astringent

ACTIVE INGREDIENT

1. Aluminium acetate

KEEP OUT OF REACH OF CHILDREN

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.

INDICATIONS & USAGE

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASTRINGENT 
aluminum acetate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM ACETATE	0.008 mg  in 4 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-005-04	4 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2015

Labeler - CA-BOTANA INTERNATIONAL (106276728)

Registrant - RODOLFO UGELSTAD (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-BOTANA INTERNATIONAL		106276728	manufacture(35192-005)