TRICALM HYDROGEL- aluminum acetate gel

Tricalm Hydrogel by

Drug Labeling and Warnings

Tricalm Hydrogel by is a Otc medication manufactured, distributed, or labeled by MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Aluminum acetate 0.2%

PURPOSE

Astringent

INDICATIONS & USAGE

For the temporary relief of minor skin irritations due to:

• poison ivy
• poison oak
• poison sumac
• insect bites
• rashes caused by soaps, detergents, cosmetics, or jewelry
• athlete's foot

WARNINGS

For external use only.

When using this product avoid contact with eyes; if contact occurs, rinse thoroughly with water

Stop use and ask a doctor if condition worsens or symptoms last for more than 7 days

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

• adults and children two years of age and older, apply to affected areas as needed or as directed by a physician
• 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, strontium chloride hexahydrate, water, xanthan gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRICALM HYDROGEL 
aluminum acetate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71207-221
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 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCINE (UNII: TE7660XO1C)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MALIC ACID (UNII: 817L1N4CKP)
STRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71207-221-02	1 in 1 CARTON	01/02/2023
1		57 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 Drug	M016	01/02/2023

Labeler - MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES (131710969)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(71207-221)