FDA Label for Holus Relief Gel, 1.7 Oz
View Indications, Usage & Precautions
Holus Relief Gel, 1.7 Oz Product Label
The following document was submitted to the FDA by the labeler of this product Nemadji Management, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Holus Relief Gel, 1.7oz - menthol, camphor gel
Topical analgesic, Over-The-Counter drug
1.7oz ounces of topical analgesic gel in a pump dispenser
Disclaimer: Most OTC drugs are not reviewed and approved by the FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active Ingredients
MENTHOL 3.9%
CAMPHOR 0.4%
Purpose
FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH SIMPLE BACKACHE, ARTHRITIS, STRAINS, BRUISES AND SPRAINS.
Directions, Holus Relief Gel, 1.7Oz
APPLY TO INFLAMED & SORE AREA NO MORE THAN 3-4 TIMES PER DAY. ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER; CHILDREN UNDER 2 YEARS OF AGE: CONSULT A PHYSICIAN.
Dosage & Administration Section
Apply to inflamed & sore area no more than 3-4 times per day.
Warnings
FOR EXTERNAL USE ONLY
AVOID CONTACT WITH EYES
DO NOT APPLY: TO WOUNDS OR DAMAGED SKIN
ALLERGY: PRODUCT CONTAINS COCONUT
THE SAFETY OF THIS PRODUCT HAS NOT BEEN DETERMINED.
THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE
Warnings, Holus Relief Gel, 1.7Oz
STOP AND ASK A PHYSICIAN (IF CONDITION WORSENS, SYMPTOMS PERSIST MORE THAN 7 DAYS, CONDITION RECURS AFTER A FEW DAYS)
IF PREGNANT OR BREASTFEEDING, SEE PHYSICIAN BEFORE USE
Inactive Ingredients, Holus Relief Gel (1.7Oz)
PURIFIED WATER, ISOPROPYL ALCOHOL, WITCH HAZEL, ALOE VERA GEL, COCONUT OIL, JOJOBA OIL, GLYCERIN, ARNICA EXTRACT, BOSWELLIA SERRATA EXTRACT, MSM (METHYLSULFONYLMETHANE), CARBOMER, VITAMIN E ACETATE, TETRASODIUM GLUTAMATE DIACETATE, SODIUM BENZOATE, SODIUM HYDROXIDE, CITRIC ACID, PEPPERMINT OIL, EUCALYPTUS OIL, WILLOW BARK EXTRACT, HEMP EXTRACT (AERIAL PARTS, 222MG)
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