Label: ASTONEA GREEN GEL- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77338-015-63, 77338-015-65, 77338-015-67 - Packager: ASTONEA LABS PRIVATE LIMITED
- 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 September 7, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses
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Warnings
For external use only
When using this product:
■Use only as directed
■Avoid contact with the eyes or on mucous membranes
■Do not apply to wounds or damaged skin
■Do not apply to irritated skin or if excessive irritation develops ■Do not bandage tightly or use with heating pad or device
Stop use and ask a doctor if:
■You experience pain, swelling or blistering of the skin
■Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
■Arthritis pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age
- Directions
- OTHER SAFETY INFORMATION
- Inactive Ingredients
- Package Labeling:
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INGREDIENTS AND APPEARANCE
ASTONEA GREEN GEL
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77338-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 g Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77338-015-65 113 g in 1 TUBE; Type 0: Not a Combination Product 08/19/2022 2 NDC:77338-015-67 907 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 08/19/2022 3 NDC:77338-015-63 2.9 g in 1 POUCH; Type 0: Not a Combination Product 09/19/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/19/2016 Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
