Swan 894 894.001/894AA rev 1 Cooling Pain Relief Gel

Drug Details [pdf]

GEL COOLING PAIN RELIEF- menthol gel
Vi-Jon, LLC

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Swan 894 894.001/894AA rev 1
Cooling Pain Relief Gel

Active ingrident

Menthol 4%

Purpose

External analgesic

Use

for temporary relief from minor aches and pains of muscles & joints associated with

simple backache
arthritis
strains
bruises
sprains

Warnings

For external use only

Flammable, keep away from fire or flame.

When using this product

avoid contact with the eyes
do not apply to wounds or damaged skin
do not bandage tightly

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

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

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: consult a doctor

Other information

store in a cool dry place with lid closed tightly

Inactive ingredients

Aloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, Ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, tocopheryl acetate, triethanolamine, water, yellow 5

Adverse Reactions Section

This product is not manufactured or distributed by Biofreeze Performance Health, distribtor of BioFreeze Cool the Pain Roll-On Fast Acting Menthol Pain Relief.

Distributed by: Vi-Jon, LLC

St. Louis MO 63114

Principal display panel

SWAN

ROLL-ON COOLING PAIN RELIEF

PAIN RELIEVING GEL

soothing menthol

For arthritis, sore muscles, joints and back pain
Diminshing scent

Compare to Biofreeze Cool the Pain Roll-On Fast Acting Menthol Pain Relief

2.5 FL OZ (74 mL)

image description

GEL COOLING PAIN RELIEF
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0894
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	160 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CHAMOMILE (UNII: FGL3685T2X)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
JUNIPER BERRY (UNII: O84B5194RL)
MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0869-0894-18	74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/13/2021	04/02/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	01/13/2021	04/02/2024

Labeler - Vi-Jon, LLC (088520668)

Registrant - Consumer Product Partners, LLC (119091520)

Name	Address	ID/FEI	Business Operations
Establishment
Consumer Product Partners, LLC		119091514	manufacture(0869-0894)

Revised: 4/2024

Document Id: 1520a4e9-8dfe-470e-e063-6394a90ac34a

Set id: e922d6c7-9564-4588-9263-7d2b97a72273

Version: 4

Effective Time: 20240402