Label: PAIN RELIEF GEL-ROLL ON- menthol gel
- NDC Code(s): 83016-331-01, 83016-331-11, 83016-331-21
- Packager: R & Y Group, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 1, 2023
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
■ Avoid contact with 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 irritation develops ■ Do not bandage ■ Wash hands after use with cool water ■ Do not use with heating pad or device ■ Store in a cool dry place
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive Ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAIN RELIEF GEL-ROLL ON
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83016-331 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.04 g in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL 95% (UNII: 7528N5H79B) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) FRANKINCENSE (UNII: R9XLF1R1WM) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83016-331-11 1 in 1 BAG 10/27/2023 1 NDC:83016-331-01 74 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:83016-331-21 3 in 1 BAG 11/01/2023 2 NDC:83016-331-01 74 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 10/27/2023 Labeler - R & Y Group, LLC (968585765) Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672) Establishment Name Address ID/FEI Business Operations Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 546872672 manufacture(83016-331)