Sure Result Sr Relief
FDA Label NDC 69837-510

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by International Brand Management, Llc for the product Sure Result Sr Relief (NDC 69837-510). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, storage and handling, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Storage And Handling

→ Inactive Ingredients

→ Otc - Questions

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Active Ingredient

Capsaicin 0.025%

Purpose

Topical Analgesic

Uses

for the temporary relief of minor aches and painsof muscles and joints associated with a simple backache,

athritis, strains and sprains

Warnings

For external use only

This is not a face cream. Do not apply to the face.
Do not use if allergic to chili peppers or if past allergic reaction to capsaicin
Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
Do not bandage tightly
Do not apply within 1 hour before or after bath, shower, hot tub, saunaor vigrous exercise
Warm water, perspiration or open pores can intensify the impact of this product and bruning sensation.
Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

When using this product Do not get into eyesand avoid contact with mucous membranes. If contact

occurs or if pain, discomfort or skin redness occurs, continuously rinse with cool water and seek medical help.

Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear

up and occur again within a few days. Stop using and get immediate medical attention if experience burning,

pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported.

Otc - Keep Out Of Reach Of Children

If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

If inhaled, remove the fresh air. If breathing is difficult, get medical attention immediately.

Directions

Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock.
Before using on children under 18 years of age consult a physician.
Apply sparingly to affected area not more than 4 times daily. However, for the first use, apply to small area to test for sensitivity or skin reaction.
Gently massage into skin until fully absorbed.
Wash hands with soap and water thoroughly after each applicationto avoid spreading to the eyes or other sensitive mucous membranes.