Label: OVERTIME-HMP- pain relief stick stick
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Contains inactivated NDC Code(s)
NDC Code(s): 27495-025-02 - Packager: Physicians Science and Nature, 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 October 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose:
- Uses:
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WARNINGS:
For external use only. Do not use in or on the eyes, mouth, mucous membranes or genitalia. Do not allow treated skin to contact infants, children or pets. Do not tightly bandage. Do not use with a heating pad. Do not use with other topical pain-relieving medications. May result in burning sensation of the skin or skin rash. Do not drive or operate heavy machinery if drowsy while using this medication. May result in stains to clothing, bedding or furniture.
- STOP USE AND ASK A PHYSICIAN:
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DO NOT USE:
On cuts, infected skin or over raw or blistered skin, on children under 12 years of age or pets, in large amounts, if allergic to any of the listed ingredients, if you are pregnant or nursing, taking anticoagulant medications. If you have questions regarding the safe use of this medication, please contact your medical provider.
- KEEP OUT OF REACH OF CHILDREN AND PETS:
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Directions:
Consult a physician prior to use. Use only as directed. Prior to first use, rub a small amount on the forearm to check for sensitivity. Gently rub over painful areas no more than 4 times daily. Do not massage into skin vigorously. Wash hands thoroughly after each use. If place into eyes, rinse with cold water and call for medical help.
- Store below 100º F / 38º C
- Inactive Ingredients:
- FORMULATED BY A PHYSICIAN
- PHYSICIAN'S SCIENCE AND NATURE, INC.
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INGREDIENTS AND APPEARANCE
OVERTIME-HMP
pain relief stick stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27495-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 15 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 25 g in 100 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHYL SULFOXIDE (UNII: YOW8V9698H) CANNABIDIOL (UNII: 19GBJ60SN5) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TOCOPHEROL (UNII: R0ZB2556P8) LOW DENSITY POLYETHYLENE (UNII: J245LN42AI) CERESIN (UNII: Q1LS2UJO3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27495-025-02 72 g in 1 JAR; Type 0: Not a Combination Product 11/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/01/2021 Labeler - Physicians Science and Nature, Inc. (012485755) Registrant - Physicians Science and Nature, Inc. (012485755) Establishment Name Address ID/FEI Business Operations GPS Associates, LLC. 096942063 manufacture(27495-025)
