Label: RELIEVEIT GEL- arnica montana gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-951-02 - 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 November 13, 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:
- When using this product:
- KEEP OUT OF REACH OF CHILDREN
- Directions:
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Other ingredients:
Calendula officinalis, Carbomer 934P, Cyclomethicone, Ethyl Alcohol,
Eucalyptus, Glycerin, Hydroxypropyl Cellulose,
Isopropyl Myristate, Juniper Oil, Laureth-7, Polyacrylamide, Polyethylene
Glycol 3350, Polysorbate 80, Propyl Gallate,
Propylene Glycol, Purified Water, Resin, Sodium
Hydroxide, Sorbic Acid, Wintergreen, and 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 GEL
arnica montana gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-951 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 7 [hp_M] in 1 g Inactive Ingredients Ingredient Name Strength 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) GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN) CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-951-02 70 g in 1 TUBE; Type 0: Not a Combination Product 10/22/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/22/2018 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(58133-951)