SIGNATURE CARE COLD AND HOT- menthol, and methyl salicylate cream

Signature Care Cold and Hot by

Drug Labeling and Warnings

Signature Care Cold and Hot by is a Otc medication manufactured, distributed, or labeled by Safeway Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Methol 10%........................................... Topical analgesic

Methyl Salicylate 30%........................... Topical analgesic

PURPOSE

Uses

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

WARNINGS

Warnings

For external use only

Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

DO NOT USE

Do not use

• on wounds or damaged skin
• with a heating pad

WHEN USING

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly

STOP USE

Stop use and ask a doctor if

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

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 a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions

• use only as directed
• adults and children 12 years of age and older:
• apply generously to affected area
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary, but not more than 4 times daily
• children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

carbomer, cetostearyl alcohol, cetyl esters, polysorbate 60, purified water, steareth-20, stearic acid, trolamine

DOSAGE & ADMINISTRATION

Distributed by:

Better Living Brands LLC

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIGNATURE CARE COLD AND HOT 
menthol, and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-861
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ESTERS WAX (UNII: D072FFP9GU)
TROLAMINE (UNII: 9O3K93S3TK)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
STEARETH-20 (UNII: L0Q8IK9E08)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-861-36	1 in 1 CARTON	01/20/2021
1		36 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	01/20/2021

Labeler - Safeway Inc. (009137209)