RELIEVEIT SPRAINGO GEL (arnica montana, ruta graveolens, symphytum officinale, mentha piperita- peppermint gel

RelieveIt SprainGo Gel by

Drug Labeling and Warnings

RelieveIt SprainGo 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 – 7%

Ruta graveolens: 2%

Symphytum Officinale (Comfrey root): 2%

Mentha Piperita: 1.25%

Purpose

Significantly reduces swelling and pain

associated with acute sprains, strains

and muscle overexertion. Reduces

discoloration from bruising.

Uses:

Sprains, Strains, Muscle/Tendon

Pulls, Tendonitis

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 any of this product’s

active or inactive ingredients do not apply

bandage tightly or use heating pad do not

resume normal activity without the advice of a

• medical professionall

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® SprainGo 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:

Harpagophytum procumbens, Carbomer 934P,
Cyclomethicone, C13/14 Isoparaffin, Ethyl Alcohol,
Eucalyptus Oil, Glycerin,
Hydroxypropylcellulose, Isopropyl Myristate, Juniper
Oil, Laureth-7, Polyacrylamide, Polyethylene Glycol
3350, Polysorbate 80, Propyl Gallate, Propylene
Glycol, Purified Water, Resin, Sodium Hydroxide,
Sorbic Acid, Wintergreen Oil 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

7 days

If pregnant or breast feeding:

ask a health professional before use

Other Information

Store at 68-77°F (20-25°C)

Principal Display Panel and Drug Facts

INGREDIENTS AND APPEARANCE

RELIEVEIT SPRAINGO GEL 
arnica montana, ruta graveolens, symphytum officinale, mentha piperita (peppermint) gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-950
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 mL
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA PIPERITA	7 [hp_M]  in 1 mL
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y)	SYMPHYTUM OFFICINALE WHOLE	2 [hp_M]  in 1 mL
RUTA GRAVEOLENS FLOWERING TOP OIL (UNII: VDI0O08XRA) (RUTA GRAVEOLENS FLOWERING TOP OIL - UNII:VDI0O08XRA)	RUTA GRAVEOLENS FLOWERING TOP OIL	2 [hp_M]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
METHYL ALCOHOL (UNII: Y4S76JWI15)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
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)
KALANCHOE PINNATA LEAF (UNII: 3R963LO08T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-950-02	70 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/17/2018
2	NDC: 58133-950-16	474 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/17/2018
3	NDC: 58133-950-37	3780 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/17/2018

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(58133-950)