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

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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Signature Care Cold & Hot Cream 1.25 oz 79861 ZDP (2021)

Active ingredients Purpose

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

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

Uses

Warnings

For external use only

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

Do not use

When using this product

Stop use and ask a doctor if

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

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

Distributed by:

Better Living Brands LLC

Made in China

79861

SIGNATURE CARE COLD AND HOT 
menthol, and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-861
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-861-361 in 1 CARTON01/20/2021
136 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/20/2021
Labeler - Safeway Inc. (009137209)

Revised: 12/2022
Document Id: efe6e7e9-63dd-16b8-e053-2995a90a1885
Set id: ab201023-e3dc-52ec-e053-2995a90a1f18
Version: 3
Effective Time: 20221215
 
Safeway Inc.