RELIEVEIT GEL MAX- arnica montana, calendula officinalis, camphora (camphor), capsaicum oleoresin (capsaicin), 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 Gel Max

Active Ingredient

Arnica montana 1X: 7%

Calendula officinalis 6X: 2%

Camphora (Camphor): 7%

Capsaicum Oleoresin (Capsaicin): 0.02%

Mentha piperita (Peppermint): 7%)

Purpose

Temporary pain relief, reduces swelling and alleviates inflammation.

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 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® Gel Max 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, Sorbitan Monooleate,
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 GEL MAX 
arnica montana, calendula officinalis, camphora (camphor), capsaicum oleoresin (capsaicin), mentha piperita (peppermint) gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-953
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)7 [hp_M]  in 1 mL
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
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.02 [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
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)  
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)  
CARBOMER 934 (UNII: Z135WT9208)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-953-0270 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/15/2018
2NDC:58133-953-16474 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/15/2018
3NDC:58133-953-373780 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/15/2018
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Registrant - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-953)

Revised: 10/2018
Document Id: 786e68a2-3b55-519f-e053-2a91aa0acf83
Set id: 786e68a2-3b54-519f-e053-2a91aa0acf83
Version: 1
Effective Time: 20181017
 
Cosmetic Specialty Labs, Inc.