SIGFORM HERBAL MUSCLE- menthol and camphor lotion 
Signature Formulations 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.

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Sigform Science & Health Herbal Muscle Lotion

Active ingredient

Menthol USP 6%
Camphor 2%

Purpose

Pain Relief

Other ingredients

Purified Signature Water™, Menthol Crystals, Methylsufonylmethane, Vegetable Glycerin, Caprylic Triglyceride, Stearic Acid, Coconut oil, Olive oil, Eucaliptus Oil, Peppermint Oil, Sweet Birch Oil, Clove Bud Oil, Aloe Vera Gel, Potassium Sorbate, Allantoin, Herbal active, Carbomer.

Uses

For the temporary relief of minor aches and pains at muscles and joints associated with sore muscles, strains, joint discomfort & arthritis.

Warnings

Discontinue use if irritation or red skin develops, and consult a physician. Application is intended for external cosmetic use only. Consult a health care professional before using this or any product during pregnancy or while breastfeeding. Do not use around the eye area. Do not use if tamper-evident seal is broken or missing. Store in cool dry place.

These statements have not been evaluated by the food and drug administration. This product is not intended to treat, cure or prevent any disease.

Keep Out of Reach of Children

Directions

Adults and children over 12 years. Massage into neck and shoulders to help relieve tension and stress. Rub into temples to help with headaches, and chest to relieve cold and flu. Apply prior to a workout or sports activity.

Manufactured in a FDA registered facility by

Signature Formulations LLC.
Phoenix, AZ

Package/Label Principal Display Panel

Sigform
SCIENCE & HEALTH

NATURALLY
PRESERVED
PARABEN FREE

HERBAL
MUSCLE
LOTION

Help Reduce…
Inflammation
Arthritis
Back Pain
Muscle Aches
Joint Pain

naturally balanced

THE NATURAL
SOLUTION THAT WORKS!

FORMULATED
WITH CARE

3.1 oz (90g)
approx 80 pumps

Carton Label

Carton Label

SIGFORM HERBAL MUSCLE 
menthol and camphor lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69257-211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRICAPRYLIN (UNII: 6P92858988)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
CLOVE OIL (UNII: 578389D6D0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ALLANTOIN (UNII: 344S277G0Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69257-211-2190 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/15/2015
Labeler - Signature Formulations LLC (079126258)
Registrant - Signature Formulations LLC (079126258)
Establishment
NameAddressID/FEIBusiness Operations
Signature Formulations LLC079126258MANUFACTURE(69257-211)

Revised: 4/2015
Document Id: 5d947e81-5153-4a99-ad13-39ba0c6915c6
Set id: 5d947e81-5153-4a99-ad13-39ba0c6915c6
Version: 1
Effective Time: 20150401
 
Signature Formulations LLC