Label: RELIEVEIT REGENERATING GEL- arnica montana, calendula officinalis, boswellia serrata, harpagophytum procumbens, kalanchoe pinnata gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-952-16, 58133-952-37 - Packager: Cosmetic Specialty Labs, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated October 22, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses:
- Warnings:
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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
- Directions:
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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:
- If pregnant or breast feeding:
- Other Information
- Principal Display Panel and Drug Facts
-
INGREDIENTS AND APPEARANCE
RELIEVEIT REGENERATING GEL
arnica montana, calendula officinalis, boswellia serrata, harpagophytum procumbens, kalanchoe pinnata gelProduct 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)