ValleGel Prep Topical Analgesic Gel

ValleGel Prep by

Drug Labeling and Warnings

ValleGel Prep by is a Otc medication manufactured, distributed, or labeled by Plum Valley Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VALLEGEL PREP- vallegel prep topical analgesic gel gel 
Plum Valley Pharma LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ValleGel Prep Topical Analgesic Gel

Active Ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with:

  • Arthritis
  • Simple Backache
  • Muscle Strains
  • Bruises
  • Muscle Sprains

Warnings

For External use only

When using this product

  • avoid contact with eyes and mucous membranes
  • do no apply to wounds or damaged skin
  • do not bandage tightly or use with a heating pad
  • use only as directed

Stop use and ask a doctor if condition worsens; symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help right away. If pregnant Or Breast-Feeding, Ask A Health Professional Before Use

Directions

  • Apply on affected area, not more than 3 to 4 times daily
  • Children under 12 years of age; consult a doctor

Other Information

  • Store at 20-25ºC (68-77ºF) Store away from heat

Inactive Ingredients

Benzyl alcohol, Carbomer, Pemulen, Polysorbate 80, Purified Water, Triethanolamine

Questions or comments? Call 1-866-248-1553

ValleGel Prep Topical Analgesic Gel

NDC: 82226-030-57

Qty 2oz (56.7G)

label

VALLEGEL PREP 
vallegel prep topical analgesic gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82226-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82226-030-5756.7 g in 1 CARTON; Type 0: Not a Combination Product05/24/202106/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/24/202106/30/2022
Labeler - Plum Valley Pharma LLC (118243219)

Revised: 7/2022
Document Id: 7ebc937b-1f6f-4b27-87be-c9cffff119aa
Set id: cd13ed14-160b-8935-e053-2995a90aa139
Version: 7
Effective Time: 20220704
 
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