CONTROL MENSTRUAL CRAMP RELIEF- menthol cream

Control Menstrual Cramp Relief by

Drug Labeling and Warnings

Control Menstrual Cramp Relief by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

CONTROL MENSTRUAL CRAMP RELIEF 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-010-01	7.5 mL in 1 PACKET; Type 0: Not a Combination Product	05/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/24/2023

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-010)