Label: ELGIN PAIN RELIEF- menthol gel
- NDC Code(s): 30056-004-03, 30056-004-04
- Packager: Eco-Logics, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- OTC-ACTIVE INGREDIENT SECTION
- PURPOSE
- Uses
- Warning
- Directions
- Ask a doctor before use if you have:
-
When Using this Product:
When Using this product:
Avoid contact with the eyes or muscous membranes
Do not apply to wounds or damaged skin
Do not use with other ointmens, creams, sprays, or linaments.
Do not apply to irritated skin or if excessive irration develops
Do not bandage
Wash hands after use with cool water
Do not use with heating pad or device.
- Stop Use and Ask Doctor If:
- If pregnant or breast feeding:
-
Keep out of reach of children.
Keep out of reach of children. If accidentally ingested, get medicalhelp or contact a Poisan Control Center immediately.
immedaAqueous (Deionized filtered water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *IlexParaguariensis leaf extract, Cinnamomum Camphora (camphor),Tocopheryl Avetate (Vitamin E Acetate), Carbomer, FD&C Blue #1, FD&C Yellow #5, Methylparaben, Triethanolamine.
- Directions:
- Other infirmation:
-
Inactive Ingredients
Inactive Ingredients:
Aqueous (Deionozed filtered water) blend of certified * Organic Aloe Barbadensis Extract, Isopropyl Alcohol, *Ilex Paraguariensis Leaf Extract, Cinnamomum Camphora (camphor),Tocopheryl Acetate (Vitamin E Acetate), Carbomer, FDC Blue #1, FDCYellow #5, Methylparaben, Triethanolamine.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ELGIN PAIN RELIEF
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30056-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 35 mg in 1 g Inactive Ingredients Ingredient Name Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) METHYLPARABEN (UNII: A2I8C7HI9T) TROLAMINE (UNII: 9O3K93S3TK) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOPROPYL ALCOHOL (UNII: ND2M416302) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30056-004-03 85 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/11/2016 2 NDC:30056-004-04 113.4 g in 1 TUBE; Type 0: Not a Combination Product 07/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/11/2016 Labeler - Eco-Logics, Inc. (047667022) Registrant - Elginex Corporation (005142799) Establishment Name Address ID/FEI Business Operations Natural Essentials,Inc. 947484713 manufacture(30056-004)
