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

RelieveIt Regenerating Gel by

Drug Labeling and Warnings

RelieveIt Regenerating 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%

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

• 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® 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

INGREDIENTS AND APPEARANCE

RELIEVEIT REGENERATING GEL 
arnica montana, calendula officinalis, boswellia serrata, harpagophytum procumbens, kalanchoe pinnata gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-952
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) (BOSWELLIA SERRATA RESIN OIL - UNII:5T1XCE6K8K)	BOSWELLIA SERRATA RESIN OIL	2 [hp_M]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	7 [hp_M]  in 1 mL
KALANCHOE PINNATA LEAF (UNII: 3R963LO08T) (KALANCHOE PINNATA LEAF - UNII:3R963LO08T)	KALANCHOE PINNATA LEAF	2 [hp_M]  in 1 mL
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) (HARPAGOPHYTUM PROCUMBENS ROOT - UNII:1OYM338E89)	HARPAGOPHYTUM PROCUMBENS ROOT	5 [hp_M]  in 1 mL
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV) (CALENDULA OFFICINALIS SEED OIL - UNII:9JS8DS42SV)	CALENDULA OFFICINALIS SEED OIL	2 [hp_M]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-952-16	474 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/17/2018
2	NDC: 58133-952-37	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(58133-952)