Drug Facts

Active Ingredients

Arnica Montana 1X - 7% HPUS

Purpose

Muscle strain, Bruising

Uses

* For the temporary relief of muscle pain and stiffness due to minor injuries, overexertion and
falls. Reduces pain, swelling and discoloration from bruises.

Warnings

For external use only.

Do not useif you are allergic to Arnica montana or to any of this product's inactive ingredients. Do not use if you are allergic to the dressing or any of its components.

When Using This Product

When using this product■ Use only as directed ■ Do not bandage tightly ■ Avoid contact with eyes ■ Do not apply to open wounds or damaged skin

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Stop and ask doctor if

Stop and ask doctor if■Condition worsens ■ Irritation occurs ■ Symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breastfeeding

If pregnant or breastfeeding, ask a health professional before use.

Directions

Adults and children 12 years of age and over

■ Clean and dry affected area ■ Remove patch from film ■ Place healing patch on intact skin ■ Patch may be worn up to 12 hours.

Children under 12 years of ageConsult a doctor

Inactive Ingredients

Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Sodium, Glycerin, Methyl- paraben, Mint Oil, Partially Neutralized Polyacrylic Acid, Polysorbate 80, Povidone-K90, Propylparaben, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Purified Water

Questions of comments?

Call toll-free 1-800-655-0252 or email: wooshinlabo-us@wooshinmed.com

Product Packaging

Label

Carton

LABOFLEX ARNIPATCH MUSCLE AND JOINT PATCH
arnica montana patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83655-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
WATER (UNII: 059QF0KO0R)
TARTARIC ACID (UNII: W4888I119H)
ALCOHOL (UNII: 3K9958V90M)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
EDETATE SODIUM (UNII: MP1J8420LU)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83655-101-15	5 g in 1 POUCH; Type 0: Not a Combination Product	09/07/2023
2	NDC:83655-101-21	5 in 1 CARTON	09/07/2023
2		5 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/07/2023

Labeler - Laboflex, Inc. (128394050)

Registrant - Laboflex, Inc. (128394050)

Name	Address	ID/FEI	Business Operations
Establishment
WOOSHIN LAPACHE d.o.o.		507385209	manufacture(83655-101)

LABOFLEX Arnipatch Arnica Muscle and Joint Patch