TRIPLE CARE PLUS ARNICA ANALGESIC - RECOVERY (methyl salicylate, camphor- synthetic, and menthol, unspecified form cream

TRIPLE CARE plus ARNICA by

Drug Labeling and Warnings

TRIPLE CARE plus ARNICA by is a Otc medication manufactured, distributed, or labeled by Paloven, Inc., Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients:	Purpose
Methyl Salicylate 15%	Topical analgesic
Camphor 6%	Topical analgesic
Menthol 6%	Topical analgesic

Uses

Temporarily relieves the minor aches and pains of muscles & joints associated with:

•   arthritis
• sprains
• general soreness
• bruises
• strains

Warnings

For external use only.

Avoid contact with eyes

Do not use

• On wounds or damaged skin
• With heating pad
• Do not bandage tightly

Stop use and consult a doctor if condition worsens or if symptoms persist for more than 7 days.

If pregnant or breast-feeding, consult a health professional before use.

• This product may cause an allergic reaction for some individuals.

Test on a small area before use.

Keep out reach of children.

If product is swallowed, seek medical help or contact a poison control center immediately.

Directions

• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.
• Children under 12 years of age: consult a doctor.

Inactive Ingredients

Water, Glyceryl Stearate SE, Butylene Glycol, Behenyl Alcohol, Stearic Acid, Polysorbate 80, Arnica Montana Flower Extract (Arnica 3%) Acrylates/C10-30, Alkyl Acrylate,Disodium EDTA, Caprylyl Glycol, Phenoxyethanol, Sodium Hydroxide

SPL UNCLASSIFIED SECTION

Distributed by
Paloven, Inc., Englewood, NJ 07631

PRINCIPAL DISPLAY PANEL - 2.8 fl oz. Tube Label

Triple Care +
ARNICA

Topical Analgesic - Recovery Cream

made in USA
2.8 fl oz.

INGREDIENTS AND APPEARANCE

TRIPLE CARE PLUS ARNICA   ANALGESIC - RECOVERY
methyl salicylate, camphor (synthetic), and menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73128-614
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Methyl Salicylate	12.42 g  in 82.8 g
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET)	Camphor (Synthetic)	4.968 g  in 82.8 g
Menthol, Unspecified form (UNII: L7T10EIP3A) (Menthol, Unspecified form - UNII:L7T10EIP3A)	Menthol, Unspecified form	4.968 g  in 82.8 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Butylene Glycol (UNII: 3XUS85K0RA)
Docosanol (UNII: 9G1OE216XY)
Stearic Acid (UNII: 4ELV7Z65AP)
Polysorbate 80 (UNII: 6OZP39ZG8H)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
Edetate Disodium (UNII: 7FLD91C86K)
Caprylyl Glycol (UNII: 00YIU5438U)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73128-614-28	82.8 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/01/2019

Labeler - Paloven, Inc. (964795868)

Establishment
Name	Address	ID/FEI	Business Operations
Hudson Cosmetics Manufacturing Corp. DBA Paramount Cosmetics		001321058	MANUFACTURE(73128-614) , PACK(73128-614)