numm cool freeze natural pain relieving gel

numm cool freeze natural pain relieving gel
SPL v1
SPL
SPL Set ID 6326fc3d-7900-4a04-8eaf-964fb25600d7
Route
topical
Published
Effective Date 2023-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (0.06 g)
Inactive Ingredients
aloe vera leaf carbomer homopolymer type c decyl glucoside water grapefruit seed oil green tea leaf filipendula ulmaria flower rosa centifolia flower oil sodium carbonate glycerin witch hazel yucca schidigera root lemon oil phenoxyethanol caprylyl glycol

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2023-03-21

Purpose

Purpose External Analgesic

Description

Menthol USP 6%


Medication Information

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Uses

Temporarily relieves minor aches and pains of muscles and joints with: simple backaches,strains, bruises, and sprains

Purpose

Purpose External Analgesic

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

aloe barbadensis leaf juice,camellia sinensis (green tea) leaf extract, caprylyl glycol carbomer, citrus grandis (grapefruit) seed extract, citrus limon (lemon) peel oil, decyl glucoside, filipendula ulmaria flower (queen of the prairie) extract, glycerin, hamamelis virginiana (witch hazel) leaf extract, phenoxyethanol, purified water, rosa damascena flower water, sodium carbornate, yucca schidigera stem extract,

Description

Menthol USP 6%

Section 51945-4

Active Ingredients

Menthol USP 6%

Question Or Comments

1-800-225-3963

Keep Out of Reach of Childern

Keep out of reach of childern


Structured Label Content

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Uses

Temporarily relieves minor aches and pains of muscles and joints with: simple backaches,strains, bruises, and sprains

Purpose

Purpose External Analgesic

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

aloe barbadensis leaf juice,camellia sinensis (green tea) leaf extract, caprylyl glycol carbomer, citrus grandis (grapefruit) seed extract, citrus limon (lemon) peel oil, decyl glucoside, filipendula ulmaria flower (queen of the prairie) extract, glycerin, hamamelis virginiana (witch hazel) leaf extract, phenoxyethanol, purified water, rosa damascena flower water, sodium carbornate, yucca schidigera stem extract,

Section 51945-4 (51945-4)

Active Ingredients

Menthol USP 6%

Question Or Comments (Question or comments)

1-800-225-3963

Keep Out of Reach of Childern (Keep out of reach of childern)

Keep out of reach of childern


Advanced Ingredient Data


Raw Label Data

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