SAINT EXTERNAL PAIN RELIEVING BANDAGE- menthol patch

SAINT External Pain Relieving Bandage by

Drug Labeling and Warnings

SAINT External Pain Relieving Bandage by is a Otc medication manufactured, distributed, or labeled by Saint Medicine, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Menthol 350mg / patch

Purpose

topical anesthetic

Uses

Temporary relief minor aches and pains of muscles and joints associated with:

Arthritis Bruises Backache Strains Sprains Legs

Warnings:

For external use only

When using this product:

Use only as directed

Avoid contact with eyes, mucous membranes or rashes

Do not apply to broken, wounded or damaged skin

Do not bandage or cover with any type of wrap except clothing

Do not use with a heating pad or apply external heat

Stop use or ask a doctor if

Rash, excessive itching or excessive skin irritation develops

If situation is not better after one treatment process (4 patches use) is complete

Condition worsens, or does not improve after regular use

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

Keep out of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

Adult and children 12 years of age and over

Clean and dry affected area

Open pouch and remove patch.

Peel off protective backing, then apply sticky side to affected area.

Remove the patch from the skin for at most 8-hour application, reattach the patch onto the protective backing for reuse.

The patch can be reused for up to 7 times

Wash hands with soap after applying patch

Children under 12 years of age

Consult a doctor before use

Other information:

This product may cause allergic reaction in some individuals.

Store in cool dry place from direct sunlight.

Inactive ingredients:

Paeonia lactiflora root, Eucommia Ulmoides bark, Carthamus tinctorius seed, Panax notoginseng root, Magnolia vine, Peppermint (Mentha × piperita) leaf, Methyl acrylate, Ethyl acrylate, Cotton fiber, Methylparaben, Propylparaben (preservatives)

SPL UNCLASSIFIED SECTION

External Analgesic For Minor Aches and Pain Relief -back, Neck, Shoulders, Elbows And Legs

EXTERNAL PAIN RELEIVING BANDAGE

Packaging

INGREDIENTS AND APPEARANCE

SAINT EXTERNAL PAIN RELIEVING BANDAGE 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72784-344(NDC: 72787-047)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	350 mg

Inactive Ingredients
Ingredient Name	Strength
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
EUCOMMIA ULMOIDES BARK (UNII: L878N1L0AR)
SAFFLOWER SEED (UNII: 8FCL6A31TX)
PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)
SCHISANDRA CHINENSIS SEED (UNII: MO9DK65G18)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
METHYL ACRYLATE (UNII: WC487PR91H)
ETHYL ACRYLATE (UNII: 71E6178C9T)
COTTON FIBER (UNII: 70LDW53ROO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	black	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72784-344-01	1 in 1 BOX	04/29/2019
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/29/2019

Labeler - Saint Medicine, Inc (081508032)