TRICALM HYDROGEL- aluminum acetate gel

TriCalm by

Drug Labeling and Warnings

TriCalm by is a Otc medication manufactured, distributed, or labeled by Modular Thermal Technologies LLC Dba Life Wear Technologies , Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Aluminum acetate (0.2%)

Purpose

Astringent

Uses

For temporary relief of minor skin irritations due to:

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

Warnings

For external use only.

When using this product

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• Do not apply to open wounds.

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.

Directions

• Adults and children two years of age and older, apply to affected area as needed or as directed by a physician. 
• Consult a physician for children under the age of two.

Inactive ingredients

Butylene glycol, caprylyl glycol, dehydroacetic acid, ethylhexylglycerin, glycine, hexylene glycol, malic acid, phenoxyethanol, purified water, strontium chloride hexahydrate, xanthan gum.

Questions?

Call 855-TRI-CALM

PRINCIPAL DISPLAY PANEL - 60 mL Vertical Carton

TRICALM®

Rapid Relief
From Itching,
Burning
& Stinging

SOOTHING
ITCH RELIEF
HYDROGEL

Steroid-Free
Aluminum Acetate Astringent

2 FL OZ (60mL)

Principal Display Panel Tube

TRICALM      Steroid-Free Hydrogel

For Itching Burning and Stinging 

                     2.0 FLOZ ( 60mL)

INGREDIENTS AND APPEARANCE

TRICALM   HYDROGEL
aluminum acetate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71207-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM ACETATE	2 mg  in 1 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: 71207-100-10	1 in 1 CARTON	11/02/2016
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71207-100-20	1 in 1 CARTON	11/02/2016
2		60 mL 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 FINAL	part347	11/01/2013

Labeler - Modular Thermal Technologies LLC Dba Life Wear Technologies (131710969)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(71207-100)