RELIEVEIT REGENERATING GEL- arnica montana, calendula officinalis, boswellia serrata, harpagophytum procumbens, kalanchoe pinnata 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 Regenerating Gel

Active Ingredient

Arnica montana 1X: 7%

Calendula officinalis 6X: 2%

Boswellia serrata: 2%

Harpagophytum procumbens(Devil's Claw): 5%

Kalanchoe Pinnata (Wonder of the World): 2%

Purpose

For recovery from muscle aches, fatigue and soreness.

Uses:

• Delayed Onset muscle Soreness (DOMS)

• Acute Muscle soreness • Tendonitis

• Muscle pulls/ aches /soreness/ strains

• Joint pain/ discomfort

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:

•Shake well before using •Apply a sufficient

amount of RelieveIt® Regenerating 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:

Carbomer 934P, Cyclomethicone, Ethyl Alcohol,
Eucalyptus Oil, Glycerin, Hydroxypropyl Cellulose,
C13/14 Isoparaffin, 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,
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

label

RELIEVEIT REGENERATING GEL 
arnica montana, calendula officinalis, boswellia serrata, harpagophytum procumbens, kalanchoe pinnata gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-952
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) (BOSWELLIA SERRATA RESIN OIL - UNII:5T1XCE6K8K) BOSWELLIA SERRATA RESIN OIL2 [hp_M]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA7 [hp_M]  in 1 mL
KALANCHOE PINNATA LEAF (UNII: 3R963LO08T) (KALANCHOE PINNATA LEAF - UNII:3R963LO08T) KALANCHOE PINNATA LEAF2 [hp_M]  in 1 mL
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) (HARPAGOPHYTUM PROCUMBENS ROOT - UNII:1OYM338E89) HARPAGOPHYTUM PROCUMBENS ROOT5 [hp_M]  in 1 mL
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV) (CALENDULA OFFICINALIS SEED OIL - UNII:9JS8DS42SV) CALENDULA OFFICINALIS SEED OIL2 [hp_M]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
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)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-952-16474 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/17/2018
2NDC:58133-952-373780 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(58133-952)

Revised: 10/2018
Document Id: 78d37379-7715-c444-e053-2a91aa0a789b
Set id: 787129c2-724d-d190-e053-2a91aa0ac6ff
Version: 2
Effective Time: 20181022
 
Cosmetic Specialty Labs, Inc.