Label: COLD ZONE PAIN RELIEVING GEL- DG HEALTH- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 72351-001-00 - Packager: SOTAC PHARMACEUTICALS PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
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 July 18, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings:
- Flammable:
- Ask a doctor before use if you have:
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When using this product:
- Avoid contact with the eyes or mucous membranes
- Do not apply to wounds or damaged skin
- Do not use with other ointments, creams, sprays or liniments
- Do not apply to irritated skin or if excessive irritated develops
- Do not bandage
- Wash hands after use with cool water
- Do not use with heating pad or device
- Stop use and ask a doctor if:
- If pregnant or breast-feeding:
- Keep out of reach of children:
- Directions:
- Other Information:
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Inactive Ingredients
Purified water, Glycerin, Isopropyl alcohol, Iso propyl myristate, Carbopol usp, Aloevera gel, Arnica montana flower extract, Articum lappa root (burdock) extract, Boswellia carterii resin extract, Calendula officinalis extract, Camellia sinensis leaf extract, Iiex paraguariensis leaf extract, Melissa officinalis (lemon balm) leaf extract, Tocopheryl acetate, Triethanolamine, Colloidal silicon dioxide, Sorbic acid, Camphor, Brillient blue, Tartrazin supra
- Cold Zone Pain Relieving Gel- DG Health
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INGREDIENTS AND APPEARANCE
COLD ZONE PAIN RELIEVING GEL- DG HEALTH
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72351-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) BRILLIANT BLUE G (UNII: M1ZRX790SI) PETROLATUM (UNII: 4T6H12BN9U) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) FRANKINCENSE (UNII: R9XLF1R1WM) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TROLAMINE (UNII: 9O3K93S3TK) SORBIC ACID (UNII: X045WJ989B) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72351-001-00 96 in 1 PACKAGE 04/12/2018 1 59.14 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/22/2018 Labeler - SOTAC PHARMACEUTICALS PRIVATE LIMITED (876894019)