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NDC 63868-0692-04 Quality Choice Ultra Strength Pain Relieving Cream 40; 100; 300 mg/g; mg/g; mg/g Details

Quality Choice Ultra Strength Pain Relieving Cream 40; 100; 300 mg/g; mg/g; mg/g

Quality Choice Ultra Strength Pain Relieving Cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). The primary component is CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.

Product Information

NDC	63868-0692
Product ID	63868-692_be62bd1e-5a06-f775-e053-2995a90aba63
Associated GPIs
GCN Sequence Number	059179
GCN Sequence Number Description	methyl salicylate/menth/camph CREAM (G) 30%-10%-4% TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	24719
HICL Sequence Number	002581
HICL Sequence Number Description	METHYL SALICYLATE/MENTHOL/CAMPHOR
Brand/Generic	Generic
Proprietary Name	Quality Choice Ultra Strength Pain Relieving Cream
Proprietary Name Suffix	Ultra Strength
Non-Proprietary Name	camphor, menthol, methyl salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40; 100; 300
Active Ingredient Units	mg/g; mg/g; mg/g
Substance Name	CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Labeler Name	QUALITY CHOICE (Chain Drug Marketing Association)
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0692-04 (63868069204)

Pricing Information	N/A
NDC Package Code	63868-692-04
Billing NDC	63868069204
Package	1 TUBE in 1 CARTON (63868-692-04) / 113 g in 1 TUBE
Marketing Start Date	2021-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL be62b6ea-09ac-0d4b-e053-2a95a90ada65 Details

Active ingredient

Camphor 4%

Menthol 10%

Methyl salicylate 30%

Purpose

Camphor - Topical analgesic

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

simple backache
arthritis
strains
sprains
bruises

Warnings

For external use only

Do not Use

on wounds or damaged skin
with a healing pad
on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have

redness over the affected area

When using this product

use only as directed
avoid contact with eyes or mucous membranes
do not bandage tightly

Stop use and ask a doctor if

skin redness or excessive irritation of the skin occurs
condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

adults and children 12 years and over; apply to affected area not more than 3 to 4 times daily
children under 12 years of age; consult a physician

Other Information

Store at 20-25 C (68-77F)
do not use if tube seal under cap is broken

Inactive Ingredients

carbomer homopolymer type c, cetostearyl alcohol, cetyl alcohol, glyceryl monostearate, methylparaben, peg-100 stearate, polysorbate 60, propylparaben, stearic acid, trolamine, water

Principal Display Panel

INGREDIENTS AND APPEARANCE

QUALITY CHOICE ULTRA STRENGTH PAIN RELIEVING CREAM ULTRA STRENGTH

camphor, menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-692
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	40 mg in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	300 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-692-04	1 in 1 CARTON	03/01/2021
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/01/2021

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Name	Address	ID/FEI	Business Operations
Establishment
ANICARE PHARMACEUTICALS PRIVATE LIMITED		916837425	manufacture(63868-692)

Revised: 3/2021

Document Id: be62bd1e-5a06-f775-e053-2995a90aba63

Set id: be62b6ea-09ac-0d4b-e053-2a95a90ada65

Version: 1

Effective Time: 20210325