Signature Care Cold & Hot Cream 1.25 Oz 79861 Zdp (2021)

SPL v5

SPL

SPL Set ID ab201023-e3dc-52ec-e053-2995a90a1f18

Route

TOPICAL

Published

Effective Date 2021-01-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (30 g) Menthol (10 g)

Inactive Ingredients

Stearic Acid Cetyl Esters Wax Trolamine Polysorbate 60 Water Steareth-20 Carbomer Homopolymer, Unspecified Type Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-01-20

Description

Active ingredients Purpose Methol 10%........................................... Topical analgesic Methyl Salicylate 30%........................... Topical analgesic

Medication Information

Warnings and Precautions

Warnings

For external use only

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

Indications and 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

Dosage and Administration

Distributed by:

Better Living Brands LLC

Made in China

Description

Active ingredients Purpose Methol 10%........................................... Topical analgesic Methyl Salicylate 30%........................... Topical analgesic

Section 44425-7

Other information

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

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product

avoid contact with eyes or mucous membranes
do not bandage tightly

Section 50570-1

Do not use

on wounds or damaged skin
with a heating pad

Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

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

Section 55106-9

Active ingredients Purpose

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

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

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Distributed by:

Better Living Brands LLC

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

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

Section 44425-7 (44425-7)

Other information

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

avoid contact with eyes or mucous membranes
do not bandage tightly

Section 50570-1 (50570-1)

Do not use

on wounds or damaged skin
with a heating pad

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

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

Section 55106-9 (55106-9)

Active ingredients Purpose

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

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

Advanced Ingredient Data

[{"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CETYL ESTERS WAX", "unii": "D072FFP9GU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 60", "unii": "CAL22UVI4M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARETH-20", "unii": "L0Q8IK9E08", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "Distributed by: Better Living Brands LLC Made in China", "34071-1": "Warnings For external use only Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.", "44425-7": "Other information store at room temperature 20-25°C (68-77°F)", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "50566-9": "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", "50567-7": "When using this product avoid contact with eyes or mucous membranes do not bandage tightly", "50570-1": "Do not use on wounds or damaged skin with a heating pad", "51727-6": "Inactive ingredients carbomer, cetostearyl alcohol, cetyl esters, polysorbate 60, purified water, steareth-20, stearic acid, trolamine", "53414-9": "If pregnant or breast-feeding, ask a health professional before use", "55105-1": "Uses temporarily relieves minor pain associated with: muscle sprains muscle strains simple backache bruises arthritis cramps", "55106-9": "Active ingredients Purpose Methol 10%........................................... Topical analgesic Methyl Salicylate 30%........................... Topical analgesic"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:58.682301 · Updated: 2026-03-14T23:13:11.905913