BLUE ANALGESIC GEL- menthol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Menthol 1.25 %, Camphor 0.5%
Available from:
CRYSTAL CURAM
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Analgesic - for temporary relief of minor aches and pains in muscles and joints associated with: - simple backaches, - strains - sprains - sports injuries - arthritis - bruises - condition worsens - symptoms last more than 7 days or clear up and occur again within a few days - redness or irritation develops
Authorization status:
OTC monograph final
Authorization number:
72886-3021-2

BLUE ANALGESIC GEL- menthol gel

CRYSTAL CURAM

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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CRYSTAL Ice Gel

Active Ingredients

Menthol 1.25 %

Camphor 0.5%

Purpose

Topical Analgesic

Uses:

for temporary relief of minor aches and pains in muscles and joints associated with:

simple backaches,

strains

sprains

sports injuries

arthritis

bruises

Warnings

FOR EXTERNAL USE ONLY

Do not use:

with other topical pain relievers

with heating pads or heating devices

When using this product

do not use in or near eyes

do not apply to wounds or damaged skin

do not bandage tightly

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

redness or irritation develops

If pregnant or breastfeeding

ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

If swallowed get Medical Help or contact a Poison Control Center right away

Directions

clean affected area before applying product

adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily

Inactive Ingredients

Carbomer, FD&C Blue No.1, Methyl Paraben Sodium, Methyl Salicylate, Propylene Glycol, Propyl

Paraben Sodium, Sodium hydroxide, Water

BLUE ANALGESIC GEL

menthol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:728 8 6 -30 21

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

1.25 g

in 10 0 g

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -

UNII:5TJD8 2A1ET)

CAMPHOR

(SYNTHETIC)

0 .5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

METHYLPARABEN SO DIUM (UNII: CR6 K9 C2NHK)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

PRO PYLPARABEN SO DIUM (UNII: 6 25NNB0 G9 N)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

CRYSTAL CURAM

METHYL SALICYLATE (UNII: LAV5U50 22Y)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:728 8 6 -30 21-2

227 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 8 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 4/0 8 /20 19

Labeler -

CRYST AL CURAM (675483147)

Revised: 4/2019

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