RELIEVEIT SPRAINGO GEL- arnica montana, ruta graveolens, symphytum officinale, mentha piperita (peppermint) gel 
Cosmetic Specialty Labs, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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RelieveIt SprainGo Gel

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

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:

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

Package label

RELIEVEIT SPRAINGO GEL 
arnica montana, ruta graveolens, symphytum officinale, mentha piperita (peppermint) gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-950
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA7 [hp_M]  in 1 mL
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA7 [hp_M]  in 1 mL
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y) SYMPHYTUM OFFICINALE WHOLE2 [hp_M]  in 1 mL
RUTA GRAVEOLENS FLOWERING TOP OIL (UNII: VDI0O08XRA) (RUTA GRAVEOLENS FLOWERING TOP OIL - UNII:VDI0O08XRA) RUTA GRAVEOLENS FLOWERING TOP OIL2 [hp_M]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-950-0270 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/17/2018
2NDC:58133-950-16474 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/17/2018
3NDC:58133-950-373780 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/17/2018
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Registrant - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-950)

Revised: 10/2018
Document Id: 7871bbc1-9f10-3f94-e053-2a91aa0a7b5a
Set id: 7871bbc1-9f0f-3f94-e053-2a91aa0a7b5a
Version: 1
Effective Time: 20181017
 
Cosmetic Specialty Labs, Inc.