Valerin by Wonder Laboratories

Valerin by

Drug Labeling and Warnings

Valerin by is a Homeopathic medication manufactured, distributed, or labeled by Wonder Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KOOL COMFORT PAIN RELIEVING ROLL-ON- menthol lotion 
Wonder Laboratories

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.

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Active Ingredient:                                                                     Purpose

Natural Menthol USP 3.5%....................................................Cooling Pain Relief

Uses:  Temporary relief of minor aches and pains of sore muscles and joints

associated with - arthritis - backache - strains - sprains

Warnings:  For external use only

Flammable:  Keep away from excessive heat or open flame

Ask a doctor before use if you have: Sensitive Skin

When Using This Product: Avoid contact with eyes or mucous membranes

- Do not apply to wounds or damaged skin - Do not use with other ointments, creams, sprays or liniments - Do not apply to irritated skin or if excessive irritation develops - Do not bandage - Wash hands after use with cool water - Do not use with heating pad or heating devices

Stop Use And Ask A Doctor If:  Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding:  Ask a health professional before use.

Keep out of reach of children:  If accidentally ingested, get medical help or contact a Poison Control Center right away

- Adults and children 2 years of age and older:  Roll on to the affected areas not more than 4 times daily; massage not necessary

- Children under 2 years of age:  Consult a physician

Other Information:  Store in a cool dry place with lid tightly closed

Inactive Ingredients: carbomer, FDC blue #1, FDC yellow #5, , glycerine, herbal extract (ILEX paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol USP, silicon dioxide, triethanolamine USP, water

KOOL COMFORT PAIN RELIEVING ROLL-ON 
menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 99528-3590
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
METHYLPARABEN (UNII: A2I8C7HI9T)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color	green (mint green)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 99528-3590-3	100 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/01/2009	07/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2009	07/15/2019

Labeler - Wonder Laboratories (078294223)

Registrant - U.S. Pharmaceuticals (009248480)

Establishment
Name	Address	ID/FEI	Business Operations
U.S. Pharmaceuticals, Inc.		009248480	manufacture(99528-3590)

Revised: 11/2019

Document Id: 97b8c8d4-d8b4-5146-e053-2a95a90a340c

34390-5

Set id: 78d151c5-b7b1-424f-9fea-5c562de1e147

Version: 3

Effective Time: 20191119