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

Manufacturer
Safeway Inc.
Effective date
2025-10-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:40:28

Label at a glance#

ProductSignature Care Cold and Hot
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure13 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

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

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

OTC - PURPOSE SECTION

Uses

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

WARNINGS SECTION

Warnings

For external use only

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

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • with a heating pad

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

DOSAGE & ADMINISTRATION SECTION

Distributed by:

Better Living Brands LLC

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7986179861

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSN5
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD5
311500menthol 10 % / methyl salicylate 30 % Topical CreamSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-861-36Signature Care Cold and Hot36 g in 1 TUBECREAM365
21130-861-36Signature Care Cold and Hot1 in 1 CARTONCREAM15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-86121130-861-36

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-12-20full-release2026-06-01 00:47:44

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Cold and HotMENTHOL, AND METHYL SALICYLATESafeway Inc.ab201023-e3dc-52ec-e053-2995a90a1f182025-10-24WarningsExact identifier
ndc (package): 21130-861-36
ndc (product): 21130-861
ndc11 (package): 21130086136
spl id: 41f03898-a230-1c28-e063-6294a90a579e
spl set id: ab201023-e3dc-52ec-e053-2995a90a1f18