QUALITY CHOICE ULTRA STRENGTH PAIN RELIEVING CREAM ULTRA STRENGTH- camphor, menthol, methyl salicylate cream

Quality Choice Ultra Strength Pain Relieving Cream by

Drug Labeling and Warnings

Quality Choice Ultra Strength Pain Relieving Cream by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (Chain Drug Marketing Association), ANICARE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2021

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

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