VALLEGEL PREP- vallegel prep topical analgesic gel gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)

Available from:

Plum Valley Pharma LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic Temporarily relieves minor pain associated with: - Arthritis - Simple Backache - Muscle Strains - Bruises - Muscle Sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

VALLEGEL PREP- VALLEGEL PREP TOPICAL ANALGESIC GEL GEL
PLUM VALLEY PHARMA LLC
_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._
----------
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)
VALLEGEL PREP
Plum Valley Pharma LLC
vallegel prep topical analgesic gel gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:82226-030
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
METHYL SALICYLATE
300 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 FORM
100 mg
in 1 g
I