CONTROL MENSTRUAL CRAMP RELIEF- menthol cream 
Cosmetic Specialty Labs, Inc.

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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KRT packet

Active Ingredient

Menthol, 3.0%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps

Warnings

for external use only

When using this product use only as directed • avoid contact with eyes or mucous membranes • do not apply to wounds or damaged skin

Stop use and ask a doctor if• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develeps

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

Adults and children over 12 years:• apply to affected area • massage into painful area until throughly absorbed into skin • repeat as necessary, but no more than 4 time daily

Children 12 years or younger: ask a doctor

Inactive Ingredients

Butylene Glycol, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Chamomilla recutita (Matricaria) Flower Extract, Citrus aurantium Dulcis (Sweet Orange) Peel Oil, Cocos nucifera (Coconut) Oil, Creatine Monohydrate, Dimethicone, Eucalyptus globulus Leaf Oil, Fragrance, Glyceryl Stearate, Laureth-4, Phenoxyethanol, Purified Water, Salvia officinalis (Sage) Extract, Sodium Laureth Sulfate, Stearic Acid, Triethanolamine.

Package label

Control

CONTROL MENSTRUAL CRAMP RELIEF 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
CHAMOMILE (UNII: FGL3685T2X)  
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
COCONUT OIL (UNII: Q9L0O73W7L)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
LAURETH-4 (UNII: 6HQ855798J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
SAGE OIL (UNII: U27K0H1H2O)  
CREATINE MONOHYDRATE (UNII: 9603LN7R2Q)  
TROLAMINE (UNII: 9O3K93S3TK)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-010-017.5 mL in 1 PACKET; Type 0: Not a Combination Product05/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/24/2023
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-010)

Revised: 5/2023
Document Id: fc73dde9-9df5-beca-e053-6394a90aaf0d
Set id: fc73dde9-9df4-beca-e053-6394a90aaf0d
Version: 1
Effective Time: 20230524
 
Cosmetic Specialty Labs, Inc.