Label: EXTRA STRENGTH- menthol and methyl salicylate oil
- NDC Code(s): 69204-027-01
- Packager: NATURES FORMULAE HEALTH PRODUCTS LTD.
- 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 February 10, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- Flammable
- DO NOT USE
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
-
OTHER SAFETY INFORMATION
Important: Read all product information before using. Keep this package for full information.
Do not use if security seal around bottle is broken or missing.
Questions? Call 1-877-275-7253
distributed by: saje natural wellness 22 east 5th ave vancouver, bc canada v5t 1g8 saje.com 1-877-ask-saje @sajewellness - DESCRIPTION
- Extra Strength USA Artwork_Box
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH
menthol and methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69204-027 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 94.41 mg in 1 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 123.74 mg in 1 mL Inactive Ingredients Ingredient Name Strength CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR) KUNZEA AMBIGUA WHOLE (UNII: R09L2486DI) LAVENDER OIL (UNII: ZBP1YXW0H8) ORIGANUM MAJORANA (UNII: R40XM3HU5X) ROSEMARY OIL (UNII: 8LGU7VM393) TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) GRAPE SEED OIL (UNII: 930MLC8XGG) PEPPERMINT OIL (UNII: AV092KU4JH) BETULA LENTA BARK (UNII: J689T0DVJQ) ELETTARIA CARDAMOMUM WHOLE (UNII: KH2S76267N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69204-027-01 1 in 1 BOX 05/13/2019 1 45 mL in 1 BOTTLE, WITH APPLICATOR; 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 05/13/2019 Labeler - NATURES FORMULAE HEALTH PRODUCTS LTD. (241385587) Establishment Name Address ID/FEI Business Operations Natures Formulae Health Products Ltd. 241385587 manufacture(69204-027)