RELIEVEIT GEL- arnica montana gel

RelieveIt Gel by

Drug Labeling and Warnings

RelieveIt Gel by is a Homeopathic medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Arnica montana 1X HPUS: 7%

Purpose

Arthritis bursitis Fibromyalgia Tendonitis Joint pain/discomfort

• Sciatica Swelling Muscle pulls/aches/soreness

Uses:

Arthritis Osteoarthritis Backaches Bursitis

Fibromyalgia Tendonitis Joint pain/discomfort

Sciatica Swelling

Warnings:

for external use only

When using this product:

use only as directed avoid contact with eyes

or mucous membranes do not apply to open

wounds, damaged, or very sensitive skin do

not use if you are allergic to Arnica montana or to any of this product’s

inactive ingredients do not apply bandage tightly or use heating pad

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact the

Poison Control Center right away.

Directions:

Adults and children 2 years and over:

Shake well before using Apply a sufficient

amount of RelieveIt® Gel to cover the

affected area Repeat as needed After

applying, wash hands with soap and water

Children under 2: consult a doctor

Other ingredients:

Calendula officinalis, Carbomer 934P, Cyclomethicone, Ethyl Alcohol,
Eucalyptus, Glycerin, Hydroxypropyl Cellulose,
Isopropyl Myristate, Juniper Oil, Laureth-7, Polyacrylamide, Polyethylene
Glycol 3350, Polysorbate 80, Propyl Gallate,
Propylene Glycol, Purified Water, Resin, Sodium
Hydroxide, Sorbic Acid, Wintergreen, and Xanthan Gum.

*These “Uses” have not been evaluated by the
Food & Drug Administration.

Stop use and ask a doctor if:

excessive redness or irritation is present

condition worsens pain persists for more than

3 days

If pregnant or breast feeding:

ask a health professional before use

Other Information

Do not use if glued carton end flaps are open or if tube seal is broken.

Store at 68-77°F (20-25°C)

Principal Display Panel and Drug Facts

INGREDIENTS AND APPEARANCE

RELIEVEIT GEL 
arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-951
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	7 [hp_M]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
METHYL ALCOHOL (UNII: Y4S76JWI15)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
JUNIPER BERRY OIL (UNII: SZH16H44UY)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
BENZOIN RESIN (UNII: GK21SBA74R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL 2-METHYLBUTYRATE (UNII: QH216IX8SV)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
PROPYL GALLATE (UNII: 8D4SNN7V92)
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
SORBIC ACID (UNII: X045WJ989B)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURETH-7 SULFATE (UNII: 9LPV636QCV)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-951-02	70 g in 1 TUBE; Type 0: Not a Combination Product	10/22/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/22/2018

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Registrant - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-951)